<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794349</url>
  </required_header>
  <id_info>
    <org_study_id>ANBL1821</org_study_id>
    <secondary_id>NCI-2018-03377</secondary_id>
    <secondary_id>ANBL1821</secondary_id>
    <secondary_id>ANBL1821</secondary_id>
    <secondary_id>U10CA180886</secondary_id>
    <nct_id>NCT03794349</nct_id>
  </id_info>
  <brief_title>Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma</brief_title>
  <official_title>A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Oncology Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab&#xD;
      work with or without eflornithine in treating patients with neuroblastoma that has come back&#xD;
      (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy,&#xD;
      such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth&#xD;
      of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping&#xD;
      them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may&#xD;
      induce changes in the body's immune system and may interfere with the ability of tumor cells&#xD;
      to grow and spread. Eflornithine blocks the production of chemicals called polyamines that&#xD;
      are important in the growth of cancer cells. Giving eflornithine with irinotecan&#xD;
      hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with&#xD;
      relapsed or refractory neuroblastoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine whether administration of eflornithine hydrochloride (eflornithine [DFMO]) in&#xD;
      combination with dinutuximab, irinotecan hydrochloride (irinotecan) and temozolomide results&#xD;
      in an improved response rate compared to dinutuximab, irinotecan and temozolomide in patients&#xD;
      with relapsed or refractory neuroblastoma and therefore is a therapeutic regimen worthy of&#xD;
      further testing in patients with newly-diagnosed high-risk neuroblastoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare progression-free survival and overall survival between patients receiving&#xD;
      dinutuximab, irinotecan and temozolomide with and without the addition of DFMO.&#xD;
&#xD;
      II. To define the toxicity profile of DFMO administered with dinutuximab, irinotecan and&#xD;
      temozolomide.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To characterize the immune and cytokine profiles of patients treated with&#xD;
      DFMO/chemotherapy/dinutuximab combination and correlate with response to therapy.&#xD;
&#xD;
      II. To evaluate GD2 levels in tumor cells from patient bone marrow samples and correlate with&#xD;
      response to therapy.&#xD;
&#xD;
      III. To explore whether the addition of DFMO to the dinutuximab and chemotherapy backbone&#xD;
      affects pain as determined by patient report and opiate usage.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 regimens.&#xD;
&#xD;
      REGIMEN A: Patients receive temozolomide orally (PO), via nasogastric (NG), or gastric (G)&#xD;
      tube on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5,&#xD;
      dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously (SC) or IV over&#xD;
      2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in&#xD;
      the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      REGIMEN B: Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21&#xD;
      of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on&#xD;
      days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5,&#xD;
      dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days&#xD;
      6-12. Treatment lasts 28 days for cycle 1 and then every 21 days for subsequent cycles up to&#xD;
      6 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 days and periodically for&#xD;
      5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response rate</measure>
    <time_frame>After every 2 cycles, for a maximum of 6 cycles of treatment</time_frame>
    <description>Responders are defined as patients who achieve a &gt;= minor response (MR) per the International Neuroblastoma Response Criteria (INRC) as their best overall response by the end of 6 cycles. The response rate to treatment will be calculated among all eligible patients, including placement of a 95% confidence interval on the response rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events &gt;= Grade 3 (Regimen B)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The percentage of patients on Regimen B with at least one Grade 3 or higher toxicity will be calculated, assessed with Common Terminology Criteria for Adverse Events version 5.0.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Immune and cytokine profiles</measure>
    <time_frame>Up to 6 cycles</time_frame>
    <description>Will be assessed by exploring the relationship between response (responder versus [vs.] non-responder) after 6 cycles on Regimen B with serum cytokine levels (IL1, IL6, tumor necrosis factor [TNF]-alpha, IFN-gamma, etc.), tumor resident immune cells (natural killer [NK] cells, tumor-associated macrophages [TAMS], tumor infiltrating lymphocyte [TILS]), and critical immune cell suppressing proteins (B7H3, PDL-1) using Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>GD2 levels in tumor cells from bone marrow samples</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be correlated with response (responder vs. non-responder) after 6 cycles using Fisher's exact test for categorical and the Wilcoxon rank-sum test for continuous factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient reported pain and opiate usage</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The occurrence of pain on each regimen as reported by patient report and opiate use will be descriptively summarized. Descriptive and summary statistics will be used to describe the scores from the Faces Pain Scale-Revised during the dinutuximab infusion and on day 1 with irinotecan and temozolomide alone for each arm separately. Confidence intervals will be constructed for the mean and frequency estimates. The day 1 patient reported outcome data are expected to be similar between the 2 regimens, while differences during or after completion of treatment may be observed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">95</enrollment>
  <condition>High Risk Neuroblastoma</condition>
  <condition>Recurrent Neuroblastoma</condition>
  <condition>Refractory Neuroblastoma</condition>
  <arm_group>
    <arm_group_label>Regimen A (chemotherapy, dinutuximab, sargramostim)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen B (eflornithine, chemotherapy, dinutuximab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21 of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Treatment duration is 28 days for cycle 1 and then every 21 days in subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dinutuximab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Regimen A (chemotherapy, dinutuximab, sargramostim)</arm_group_label>
    <arm_group_label>Regimen B (eflornithine, chemotherapy, dinutuximab)</arm_group_label>
    <other_name>Ch 14.18UTC</other_name>
    <other_name>Ch14.18</other_name>
    <other_name>Dinutuximab Beta</other_name>
    <other_name>MOAB Ch14.18</other_name>
    <other_name>monoclonal antibody Ch14.18</other_name>
    <other_name>Qarziba</other_name>
    <other_name>Unituxin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eflornithine Hydrochloride</intervention_name>
    <description>Given PO or via NG or G tube</description>
    <arm_group_label>Regimen B (eflornithine, chemotherapy, dinutuximab)</arm_group_label>
    <other_name>alpha-Difluoromethylornithine hydrochloride</other_name>
    <other_name>Eflornithine.HCl</other_name>
    <other_name>MDL 71782</other_name>
    <other_name>Ornidyl</other_name>
    <other_name>RMI-71782</other_name>
    <other_name>Vaniqa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Regimen A (chemotherapy, dinutuximab, sargramostim)</arm_group_label>
    <arm_group_label>Regimen B (eflornithine, chemotherapy, dinutuximab)</arm_group_label>
    <other_name>Campto</other_name>
    <other_name>Camptosar</other_name>
    <other_name>Camptothecin 11</other_name>
    <other_name>Camptothecin-11</other_name>
    <other_name>CPT 11</other_name>
    <other_name>CPT-11</other_name>
    <other_name>Irinomedac</other_name>
    <other_name>Irinotecan Hydrochloride Trihydrate</other_name>
    <other_name>Irinotecan Monohydrochloride Trihydrate</other_name>
    <other_name>U-101440E</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sargramostim</intervention_name>
    <description>Given SC or IV</description>
    <arm_group_label>Regimen A (chemotherapy, dinutuximab, sargramostim)</arm_group_label>
    <arm_group_label>Regimen B (eflornithine, chemotherapy, dinutuximab)</arm_group_label>
    <other_name>23-L-Leucinecolony-Stimulating Factor 2</other_name>
    <other_name>DRG-0012</other_name>
    <other_name>Leukine</other_name>
    <other_name>Prokine</other_name>
    <other_name>rhu GM-CFS</other_name>
    <other_name>Sagramostim</other_name>
    <other_name>Sargramostatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Given PO or via NG or G tube</description>
    <arm_group_label>Regimen A (chemotherapy, dinutuximab, sargramostim)</arm_group_label>
    <arm_group_label>Regimen B (eflornithine, chemotherapy, dinutuximab)</arm_group_label>
    <other_name>CCRG-81045</other_name>
    <other_name>Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-</other_name>
    <other_name>M &amp; B 39831</other_name>
    <other_name>M and B 39831</other_name>
    <other_name>Methazolastone</other_name>
    <other_name>RP-46161</other_name>
    <other_name>SCH 52365</other_name>
    <other_name>Temcad</other_name>
    <other_name>Temodal</other_name>
    <other_name>Temodar</other_name>
    <other_name>Temomedac</other_name>
    <other_name>TMZ</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have had histologic verification of neuroblastoma or&#xD;
             ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with&#xD;
             elevated urinary catecholamines (i.e. &gt; 2 x upper limit of normal [ULN]), at the time&#xD;
             of initial diagnosis.&#xD;
&#xD;
          -  For the purposes of this study, aggressive multidrug chemotherapy is defined as&#xD;
             chemotherapy including 2 or more agents that must include an alkylating agent and a&#xD;
             platinum-containing compound as intended to treat high-risk disease. The doses of&#xD;
             chemotherapy must be comparable to those used in frontline high-risk neuroblastoma&#xD;
             therapies (examples include A3973, ANBL0532, ANBL09P1, ANBL12P1, and ANBL1531).&#xD;
             Patients must have ONE of the following:&#xD;
&#xD;
               -  First episode of recurrent high-risk disease following completion of aggressive&#xD;
                  multi-drug frontline high-risk therapy.&#xD;
&#xD;
               -  First episode of progressive high-risk disease during aggressive multi-drug&#xD;
                  frontline therapy.&#xD;
&#xD;
               -  Primary resistant/refractory disease (less than partial response by International&#xD;
                  Neuroblastoma Response Criteria [INRC]) detected at the conclusion of at least 4&#xD;
                  cycles of aggressive multidrug induction chemotherapy on or according to a&#xD;
                  high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1,&#xD;
                  ANBL12P1, ANBL1531, etc.).&#xD;
&#xD;
          -  Patients must have at least ONE of the following at the time of enrollment:&#xD;
&#xD;
               -  Measurable tumor on magnetic resonance imaging (MRI) or computed tomography (CT)&#xD;
                  scan. Measurable is defined as &gt;= 10 mm in at least one dimension on&#xD;
                  spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates&#xD;
                  increased fludeoxyglucose F-18 (FDG) uptake on positron emission tomography (PET)&#xD;
                  scan.&#xD;
&#xD;
               -  MIBG-avid lesion detected on MIBG scan with positive uptake at a minimum of one&#xD;
                  site. This site must represent disease recurrence after completion of therapy,&#xD;
                  progressive disease on therapy, or refractory disease during induction.&#xD;
&#xD;
               -  Patients with resistant/refractory soft tissue disease that is not MIBG avid or&#xD;
                  does not demonstrate increased FDG uptake on PET scan must undergo biopsy to&#xD;
                  document the presence of viable neuroblastoma. Biopsy is not required for&#xD;
                  patients who have a new site of soft tissue disease (radiographic evidence of&#xD;
                  disease progression) regardless of whether progression occurs while receiving&#xD;
                  therapy or after completion of therapy.&#xD;
&#xD;
               -  Patients with bone marrow disease only will be eligible if they have more than 5%&#xD;
                  disease involvement (documented neuroblastoma cells) in at least one sample from&#xD;
                  bilateral bone marrow biopsies.&#xD;
&#xD;
               -  Note: Patients with elevated catecholamines (i.e. &gt; 2 x ULN) only are NOT&#xD;
                  eligible for this study.&#xD;
&#xD;
          -  Patients must have a performance status corresponding to Eastern Cooperative Oncology&#xD;
             Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients &gt; 16 years of age and&#xD;
             Lansky for patients =&lt; 16 years of age.&#xD;
&#xD;
          -  Primary refractory/resistant patients must have received at least 4 cycles of&#xD;
             frontline high-risk chemotherapy. Frontline therapy may also have included surgery,&#xD;
             chemotherapy, autologous stem cell transplantation (SCT) +/- MIBG, immunotherapy,&#xD;
             radiotherapy, and retinoids but must NOT have received second line therapy for&#xD;
             resistant/refractory, relapsed, or progressive disease. Patients who received&#xD;
             intensified therapy for poor induction response or refractory disease (e.g. MIBG) will&#xD;
             be considered to have received second line therapy and will not be eligible.&#xD;
&#xD;
          -  At least 14 days must have elapsed since completion of myelosuppressive therapy.&#xD;
&#xD;
          -  Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced&#xD;
             platelet or absolute neutrophil count [ANC] counts): &gt;= 7 days after the last dose of&#xD;
             agent.&#xD;
&#xD;
          -  Antibodies: &gt;= 21 days must have elapsed from infusion of last dose of antibody, and&#xD;
             toxicity related to prior antibody therapy must be recovered to grade =&lt; 1.&#xD;
&#xD;
          -  No interim time prior to study entry is required following prior radiation therapy&#xD;
             (RT) for non-target lesions. However, patients must not have received radiation for a&#xD;
             minimum of 4 weeks prior to study entry at the site of any lesion that will be&#xD;
             identified as a target lesion to measure tumor response. Lesions that have been&#xD;
             previously radiated cannot be used as target lesions unless there is radiographic&#xD;
             evidence of progression at the site following radiation or a biopsy done following&#xD;
             radiation shows viable neuroblastoma. Palliative radiation while on study is not&#xD;
             permitted.&#xD;
&#xD;
          -  Patients are eligible &gt;= 6 weeks after autologous stem cell transplants or stem cell&#xD;
             infusions (including stem cell infusions given as supportive care following 131 I-MIBG&#xD;
             therapy) as long as hematologic and other eligibility criteria have been met.&#xD;
&#xD;
          -  Patients are eligible &gt;= 6 weeks after therapeutic 131 I-MIBG provided that all other&#xD;
             eligibility criteria are met.&#xD;
&#xD;
          -  Subjects who have previously received anti-GD2 monoclonal antibodies with or without&#xD;
             retinoids for biologic therapy are eligible unless they have had progressive disease&#xD;
             while receiving prior anti-GD2 therapy or progressed/relapsed within 3 months of&#xD;
             receiving anti-GD2 therapy. However, eligible patients may NOT have received anti-GD2&#xD;
             monoclonal antibodies in combination with chemotherapy.&#xD;
&#xD;
          -  Subjects who have received autologous marrow infusions or autologous stem cell&#xD;
             infusions that were purged using monoclonal antibody linked to beads are eligible.&#xD;
&#xD;
          -  Subjects who have previously received DFMO are eligible for this study provided they&#xD;
             have not had progressive disease while receiving DFMO or progressed/relapsed within 3&#xD;
             months of completing DFMO.&#xD;
&#xD;
          -  Patients must not have received long-acting myeloid growth factors (e.g.&#xD;
             pegfilgrastim) within 14 days of entry on this study. Seven days must have elapsed&#xD;
             since administration of a short-acting myeloid growth factor.&#xD;
&#xD;
          -  For patients with solid tumors (without marrow involvement) including status post SCT:&#xD;
             peripheral absolute neutrophil count (ANC) &gt;= 750/uL (within 7 days prior to&#xD;
             enrollment).&#xD;
&#xD;
          -  For patients with solid tumors (without marrow involvement) including status post SCT:&#xD;
             platelet count &gt;= 75,000/uL (transfusion independent) (within 7 days prior to&#xD;
             enrollment).&#xD;
&#xD;
          -  Patients known to have bone marrow involvement with neuroblastoma are eligible&#xD;
             provided that minimum ANC and transfusion independent platelet count criteria are met&#xD;
             (as above). However, these patients are not evaluable for hematological toxicity.&#xD;
&#xD;
          -  Creatinine clearance or radioisotope GFR &gt;= 70 mL/min/1.73 m^2 or a serum creatinine&#xD;
             based on age/gender as follows:&#xD;
&#xD;
               -  1 to &lt; 2 years (male 0.6 mg/dL, female 0.6 mg/dL)&#xD;
&#xD;
               -  2 to &lt; 6 years (male 0.8 mg/dL, female 0.8 mg/dL)&#xD;
&#xD;
               -  6 to &lt; 10 years (male 1 mg/dL, female 1 mg/dL)&#xD;
&#xD;
               -  10 to &lt; 13 years (male 1.2 mg/dL, female 1.2 mg/dL)&#xD;
&#xD;
               -  13 to &lt; 16 years (male 1.5 mg/dL, female 1.4 mg/dL)&#xD;
&#xD;
               -  &gt;= 16 years (male 1.7 mg/dL, female 1.4 mg/dL) (within 7 days prior to&#xD;
                  enrollment).&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x ULN for age (within 7 days prior to enrollment).&#xD;
&#xD;
          -  Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =&lt; 5.0 x&#xD;
             ULN for age (=&lt; 225 U/L). For the purpose of this study, the ULN for SGPT is 45 U/L&#xD;
             (within 7 days prior to enrollment).&#xD;
&#xD;
          -  Shortening fraction of &gt;= 27% by echocardiography (ECHO) (within 7 days prior to&#xD;
             enrollment).&#xD;
&#xD;
          -  Ejection fraction of &gt;= 50% by ECHO or gated radionuclide study (within 7 days prior&#xD;
             to enrollment).&#xD;
&#xD;
          -  No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen&#xD;
             requirement, and room air pulse oximetry &gt; 94% if there is a clinical indication for&#xD;
             pulse oximetry. Normal pulmonary function tests in patients who are capable of&#xD;
             cooperating with testing (including diffusion capacity of the lung for carbon monoxide&#xD;
             [DLCO)] are required if there is a clinical indication for determination. For patients&#xD;
             who do not have respiratory symptoms, full pulmonary function tests (PFTs) are NOT&#xD;
             required.&#xD;
&#xD;
          -  Patients with a history of central nervous system (CNS) disease must have no clinical&#xD;
             or radiological evidence of active CNS disease at the time of study enrollment.&#xD;
&#xD;
          -  Patients with seizure disorders may be enrolled if seizures are well controlled on&#xD;
             anti-convulsants.&#xD;
&#xD;
          -  CNS toxicity =&lt; grade 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men and women of childbearing potential and their partners must agree to use adequate&#xD;
             contraception while enrolled on this study. Based on the established teratogenic&#xD;
             potential of alkylating agents, pregnant women will be excluded from this study.&#xD;
             Because of potential risks to breastfed infants due to drug metabolites that could be&#xD;
             excreted in breast milk, female patients who are lactating must agree to stop&#xD;
             breastfeeding or will otherwise be excluded from this study. Females of childbearing&#xD;
             potential must have a negative pregnancy test to be eligible for this study.&#xD;
&#xD;
          -  Patients with only elevated catecholamines (i.e. &gt; 2 x ULN) are NOT eligible for this&#xD;
             study.&#xD;
&#xD;
          -  Patients must have been off pharmacologic doses of systemic steroids for at least 7&#xD;
             days prior to enrollment. Patients who require or are likely to require pharmacologic&#xD;
             doses of systemic corticosteroids while receiving treatment on this study are&#xD;
             ineligible. The only exception is for patients known to require 2 mg/kg or less of&#xD;
             hydrocortisone (or an equivalent dose of an alternative corticosteroid) as&#xD;
             premedication for blood product administration in order to avoid allergic transfusion&#xD;
             reactions. The use of conventional doses of inhaled steroids for the treatment of&#xD;
             asthma is permitted, as is the use of physiologic doses of steroids for patients with&#xD;
             known adrenal insufficiency.&#xD;
&#xD;
        Patients on any other immunosuppressive medications (e.g. cyclosporine, tacrolimus) are not&#xD;
        eligible.&#xD;
&#xD;
          -  Patients must not have received prior treatment with irinotecan and temozolomide.&#xD;
&#xD;
          -  Patients must not have received enzyme-inducing anticonvulsants including phenytoin,&#xD;
             phenobarbital, or carbamazepine for at least 7 days prior to study enrollment.&#xD;
             Patients receiving non-enzyme inducing anticonvulsants such as gabapentin, valproic&#xD;
             acid, or levetiracetam will be eligible.&#xD;
&#xD;
          -  Patients who have received drugs that are strong inducers or inhibitors of CYP3A4&#xD;
             within 7 days prior to study enrollment are not eligible.&#xD;
&#xD;
          -  Patients must not have been diagnosed with myelodysplastic syndrome or with any&#xD;
             malignancy other than neuroblastoma.&#xD;
&#xD;
          -  Patients with symptoms of congestive heart failure are not eligible.&#xD;
&#xD;
          -  Patients must not have &gt;= grade 2 diarrhea.&#xD;
&#xD;
          -  Patients who are unable to tolerate oral/nasogastric/gastrostomy medications will not&#xD;
             be eligible for this trial. Additionally, patients with significant malabsorption will&#xD;
             not be eligible for this trial.&#xD;
&#xD;
          -  Patients must not have uncontrolled infection.&#xD;
&#xD;
          -  Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or&#xD;
             reactions that required permanent discontinuation of the anti-GD2 therapy are not&#xD;
             eligible.&#xD;
&#xD;
          -  Patients with a significant intercurrent illness (any ongoing serious medical problem&#xD;
             unrelated to cancer or its treatment) that is not covered by the detailed exclusion&#xD;
             criteria and that is expected to interfere with the action of study agents or to&#xD;
             significantly increase the severity of the toxicities experienced from study treatment&#xD;
             are not eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret E Macy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>205-638-9285</phone>
      <email>oncologyresearch@peds.uab.edu</email>
    </contact>
    <investigator>
      <last_name>Elizabeth D. Alva</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3591</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>501-364-7373</phone>
    </contact>
    <investigator>
      <last_name>David L. Becton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Downey Medical Center</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>626-564-3455</phone>
    </contact>
    <investigator>
      <last_name>Robert M. Cooper</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miller Children's and Women's Hospital Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>562-933-5600</phone>
    </contact>
    <investigator>
      <last_name>Jacqueline N. Casillas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-361-4110</phone>
    </contact>
    <investigator>
      <last_name>Leo Mascarenhas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Valley Children's Hospital</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93636</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>559-353-3000</phone>
      <email>Research@valleychildrens.org</email>
    </contact>
    <investigator>
      <last_name>Karen S. Fernandez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Aarati V. Rao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>714-509-8646</phone>
      <email>oncresearch@choc.org</email>
    </contact>
    <investigator>
      <last_name>Elyssa M. Rubin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-694-0012</phone>
      <email>ccto-office@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Jay Michael S. Balagtas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-734-3089</phone>
    </contact>
    <investigator>
      <last_name>Marcio H. Malogolowkin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>858-966-5934</phone>
    </contact>
    <investigator>
      <last_name>William D. Roberts</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center-Mission Bay</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-827-3222</phone>
      <email>cancertrials@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Arun A. Rangaswami</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-764-5056</phone>
      <email>josh.b.gordon@nsmtp.kp.org</email>
    </contact>
    <investigator>
      <last_name>Margaret E. Macy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-839-6000</phone>
    </contact>
    <investigator>
      <last_name>Jennifer J. Clark</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>860-545-9981</phone>
    </contact>
    <investigator>
      <last_name>Michael S. Isakoff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>203-785-5702</phone>
      <email>canceranswers@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Farzana Pashankar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alfred I duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Ramamoorthy Nagasubramanian</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>202-884-2549</phone>
    </contact>
    <investigator>
      <last_name>Jeffrey S. Dome</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Golisano Children's Hospital of Southwest Florida</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>239-343-5333</phone>
      <email>molly.arnstrom@leehealth.org</email>
    </contact>
    <investigator>
      <last_name>Emad K. Salman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>352-273-8010</phone>
      <email>cancer-center@ufl.edu</email>
    </contact>
    <investigator>
      <last_name>William B. Slayton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital/Joe DiMaggio Children's Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>954-265-1847</phone>
      <email>OHR@mhs.net</email>
    </contact>
    <investigator>
      <last_name>Iftikhar Hanif</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Clinic-Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Ramamoorthy Nagasubramanian</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>305-243-2647</phone>
    </contact>
    <investigator>
      <last_name>Julio C. Barredo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-624-2778</phone>
    </contact>
    <investigator>
      <last_name>Ziad A. Khatib</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arnold Palmer Hospital for Children</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>321-841-5357</phone>
      <email>Jennifer.spinelli@orlandohealth.com</email>
    </contact>
    <investigator>
      <last_name>Amy A. Smith</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Ramamoorthy Nagasubramanian</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins All Children's Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>727-767-4784</phone>
      <email>Ashley.Repp@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Jonathan L. Metts</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Hospital</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>561-881-2815</phone>
    </contact>
    <investigator>
      <last_name>Muaz A. Alrazzak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta - Egleston</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>404-785-2025</phone>
      <email>Leann.Schilling@choa.org</email>
    </contact>
    <investigator>
      <last_name>Kelly C. Goldsmith</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>912-350-7887</phone>
      <email>Lorraine.OHara@hcahealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Andrew L. Pendleton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-983-6090</phone>
    </contact>
    <investigator>
      <last_name>Wade T. Kyono</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Martha M. Pacheco</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lurie Children's Hospital-Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-880-4562</phone>
    </contact>
    <investigator>
      <last_name>Elizabeth A. Sokol</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Illinois</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-355-3046</phone>
    </contact>
    <investigator>
      <last_name>Mary L. Schmidt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-702-8222</phone>
      <email>cancerclinicaltrials@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Susan L. Cohn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Jude Midwest Affiliate</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-226-4343</phone>
    </contact>
    <investigator>
      <last_name>Prerna Kumar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-248-1199</phone>
    </contact>
    <investigator>
      <last_name>Sandeep Batra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Vincent Indianapolis Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>317-338-2194</phone>
      <email>research@stvincent.org</email>
    </contact>
    <investigator>
      <last_name>Bassem I. Razzouk</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Blank Children's Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>515-241-8912</phone>
      <email>samantha.mallory@unitypoint.org</email>
    </contact>
    <investigator>
      <last_name>Samantha L. Mallory</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa/Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-237-1225</phone>
    </contact>
    <investigator>
      <last_name>David S. Dickens</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky/Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>859-257-3379</phone>
    </contact>
    <investigator>
      <last_name>James T. Badgett</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Norton Children's Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>502-629-5500</phone>
      <email>CancerResource@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Ashok B. Raj</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CHResearch@lcmchealth.org</email>
    </contact>
    <investigator>
      <last_name>Lolie C. Yu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>504-842-8084</phone>
      <email>Elisemarie.curry@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>Craig Lotterman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Maine Children's Cancer Program</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-396-7581</phone>
      <email>sverwys@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Sei-Gyung K. Sze</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland/Greenebaum Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-888-8823</phone>
    </contact>
    <investigator>
      <last_name>Teresa A. York</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-601-6120</phone>
      <email>pridgely@lifebridgehealth.org</email>
    </contact>
    <investigator>
      <last_name>Jason M. Fixler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Allen R. Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-442-3324</phone>
    </contact>
    <investigator>
      <last_name>Suzanne Shusterman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>C S Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-865-1125</phone>
    </contact>
    <investigator>
      <last_name>Rajen Mody</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Roland L. Chu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wayne State University/Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Michigan State University Clinical Center</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824-7016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>517-975-9547</phone>
    </contact>
    <investigator>
      <last_name>Laura E. Agresta</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital at Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bronson Methodist Hospital</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota - Minneapolis</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>612-813-5193</phone>
    </contact>
    <investigator>
      <last_name>Michael K. Richards</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Minnesota/Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>612-624-2620</phone>
    </contact>
    <investigator>
      <last_name>Emily G. Greengard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>601-815-6700</phone>
    </contact>
    <investigator>
      <last_name>Betty L. Herrington</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospitals and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>816-302-6808</phone>
      <email>rryan@cmh.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin F. Ginn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Frederick S. Huang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>314-251-7066</phone>
    </contact>
    <investigator>
      <last_name>Robin D. Hanson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital and Medical Center of Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-955-3949</phone>
    </contact>
    <investigator>
      <last_name>Jill C. Beck</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-559-6941</phone>
      <email>unmcrsa@unmc.edu</email>
    </contact>
    <investigator>
      <last_name>Jill C. Beck</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunrise Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases/Cure 4 the Kids Foundation</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Summerlin Hospital Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>201-996-2879</phone>
    </contact>
    <investigator>
      <last_name>Katharine Offer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-971-5900</phone>
    </contact>
    <investigator>
      <last_name>Kathryn L. Laurie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>518-262-5513</phone>
    </contact>
    <investigator>
      <last_name>Lauren R. Weintraub</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Lisa Gennarini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-767-9355</phone>
      <email>askroswell@roswellpark.org</email>
    </contact>
    <investigator>
      <last_name>Clare J. Twist</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-263-4432</phone>
      <email>cancertrials@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Chana L. Glasser</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Steven and Alexandra Cohen Children's Medical Center of New York</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-470-3460</phone>
    </contact>
    <investigator>
      <last_name>Julie I. Krystal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-305-6361</phone>
      <email>nr2616@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Nobuko Hijiya</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>State University of New York Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>315-464-5476</phone>
    </contact>
    <investigator>
      <last_name>Philip M. Monteleone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center/Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-804-9376</phone>
    </contact>
    <investigator>
      <last_name>Joel A. Kaplan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-275-3853</phone>
    </contact>
    <investigator>
      <last_name>Lars M. Wagner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>336-713-6771</phone>
    </contact>
    <investigator>
      <last_name>Thomas W. McLean</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Medical Center of Akron</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>330-543-3193</phone>
    </contact>
    <investigator>
      <last_name>Erin Wright</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>513-636-2799</phone>
      <email>cancer@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Robin E. Norris</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rainbow Babies and Childrens Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>216-844-5437</phone>
    </contact>
    <investigator>
      <last_name>Duncan S. Stearns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-223-8100</phone>
      <email>TaussigResearch@ccf.org</email>
    </contact>
    <investigator>
      <last_name>Rabi Hanna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>614-722-6039</phone>
      <email>Melinda.Triplet@nationwidechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Mark A. Ranalli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dayton Children's Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-228-4055</phone>
    </contact>
    <investigator>
      <last_name>Mukund G. Dole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>419-824-1842</phone>
      <email>PCIOncResearch@promedica.org</email>
    </contact>
    <investigator>
      <last_name>Jamie L. Dargart</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>405-271-8777</phone>
      <email>ou-clinical-trials@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Rene Y. McNall-Knapp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-494-1080</phone>
      <email>trials@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Susan J. Lindemulder</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Cedar Crest</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>610-402-9543</phone>
      <email>Morgan_M.Horton@lvhn.org</email>
    </contact>
    <investigator>
      <last_name>Jacob A. Troutman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn State Children's Hospital</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>717-531-6012</phone>
    </contact>
    <investigator>
      <last_name>Lisa M. McGregor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>267-425-5544</phone>
      <email>CancerTrials@email.chop.edu</email>
    </contact>
    <investigator>
      <last_name>Rochelle Bagatell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-692-8570</phone>
      <email>jean.tersak@chp.edu</email>
    </contact>
    <investigator>
      <last_name>Jean M. Tersak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>401-444-1488</phone>
    </contact>
    <investigator>
      <last_name>Jennifer J. Welch</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Richland Hospital</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-241-6251</phone>
    </contact>
    <investigator>
      <last_name>Stuart L. Cramer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BI-LO Charities Children's Cancer Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-241-6251</phone>
    </contact>
    <investigator>
      <last_name>Aniket Saha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>605-312-3320</phone>
      <email>OncologyClinicalTrialsSF@SanfordHealth.org</email>
    </contact>
    <investigator>
      <last_name>Kayelyn J. Wagner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>East Tennessee Childrens Hospital</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>865-541-8266</phone>
    </contact>
    <investigator>
      <last_name>Susan E. Spiller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-226-4343</phone>
      <email>referralinfo@stjude.org</email>
    </contact>
    <investigator>
      <last_name>Sara M. Federico</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at TriStar Centennial</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>615-342-1919</phone>
    </contact>
    <investigator>
      <last_name>Jennifer A. Domm</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University/Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-811-8480</phone>
    </contact>
    <investigator>
      <last_name>Daniel J. Benedetti</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dell Children's Medical Center of Central Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>512-628-1902</phone>
      <email>TXAUS-DL-SFCHemonc.research@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Shannon M. Cohn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Driscoll Children's Hospital</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>361-694-5311</phone>
      <email>Crystal.DeLosSantos@dchstx.org</email>
    </contact>
    <investigator>
      <last_name>Nkechi I. Mba</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>972-566-5588</phone>
    </contact>
    <investigator>
      <last_name>Stanton C. Goldman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Tanya C. Watt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>682-885-2103</phone>
      <email>CookChildrensResearch@cookchildrens.org</email>
    </contact>
    <investigator>
      <last_name>Chelsee Greer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>713-798-1354</phone>
      <email>burton@bcm.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah B. Whittle</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-704-2894</phone>
      <email>bridget.medina@christushealth.org</email>
    </contact>
    <investigator>
      <last_name>Timothy C. Griffin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-450-3800</phone>
      <email>phoresearchoffice@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>Anne-Marie R. Langevin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>801-585-5270</phone>
    </contact>
    <investigator>
      <last_name>Matthew Dietz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Vermont and State Agricultural College</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>802-656-8990</phone>
      <email>rpo@uvm.edu</email>
    </contact>
    <investigator>
      <last_name>Jessica L. Heath</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>434-243-6303</phone>
      <email>uvacancertrials@hscmail.mcc.virginia.edu</email>
    </contact>
    <investigator>
      <last_name>William C. Petersen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of The King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>757-668-7243</phone>
      <email>CCBDCresearch@chkd.org</email>
    </contact>
    <investigator>
      <last_name>Eric J. Lowe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-987-2000</phone>
    </contact>
    <investigator>
      <last_name>Sarah E. Leary</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center and Children's Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-228-6618</phone>
      <email>HopeBeginsHere@providence.org</email>
    </contact>
    <investigator>
      <last_name>Judy L. Felgenhauer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mary Bridge Children's Hospital and Health Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>253-403-1461</phone>
      <email>research@multicare.org</email>
    </contact>
    <investigator>
      <last_name>Robert G. Irwin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>253-968-6144</phone>
      <email>Melissa.a.forouhar.mil@mail.mil</email>
    </contact>
    <investigator>
      <last_name>Melissa A. Forouhar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Virginia University Healthcare</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>304-293-7374</phone>
      <email>cancertrialsinfo@hsc.wvu.edu</email>
    </contact>
    <investigator>
      <last_name>Ashley E. Meyer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-622-8922</phone>
    </contact>
    <investigator>
      <last_name>Kenneth B. De Santes</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-955-4727</phone>
      <email>MACCCTO@mcw.edu</email>
    </contact>
    <investigator>
      <last_name>Angela Steineck</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Hunter Children's Hospital</name>
      <address>
        <city>Hunter Regional Mail Centre</city>
        <state>New South Wales</state>
        <zip>2310</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>(02) 4985 5180</phone>
    </contact>
    <investigator>
      <last_name>Elizabeth L. Hesketh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sydney Children's Hospital</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>(02) 9382-1721</phone>
    </contact>
    <investigator>
      <last_name>Draga Barbaric</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>61-2-9845 1400</phone>
    </contact>
    <investigator>
      <last_name>Bhavna Padhye</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queensland Children's Hospital</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>61 7 3068 1111</phone>
    </contact>
    <investigator>
      <last_name>Wayne D. Nicholls</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Women's and Children's Hospital-Adelaide</name>
      <address>
        <city>North Adelaide</city>
        <state>South Australia</state>
        <zip>5006</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>(08) 8161 7327</phone>
      <email>cywhs.oncsec@health.sa.gov.au</email>
    </contact>
    <investigator>
      <last_name>Maria L. Kirby</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Children's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>61 3 9345 5656</phone>
      <email>Jordan.Hansford@rch.org.au</email>
    </contact>
    <investigator>
      <last_name>Martin A. Campbell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Perth Children's Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Marianne B. Phillips</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CancerCare Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-561-1026</phone>
      <email>ctu_web@cancercare.mb.ca</email>
    </contact>
    <investigator>
      <last_name>Issai M. Vanan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Janeway Child Health Centre</name>
      <address>
        <city>Saint John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-722-1126</phone>
    </contact>
    <investigator>
      <last_name>Lisa A. Goodyear</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>902-470-8520</phone>
      <email>Research@iwk.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Craig Erker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McMaster Children's Hospital at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>905-521-2100</phone>
    </contact>
    <investigator>
      <last_name>Uma H. Athale</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>613-549-6666</phone>
      <email>cc-clinicaltrials@kgh.kari.net</email>
    </contact>
    <investigator>
      <last_name>Laura Wheaton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>519-685-8306</phone>
    </contact>
    <investigator>
      <last_name>Shayna M. Zelcer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>416-813-7654</phone>
      <email>ask.CRS@sickkids.ca</email>
    </contact>
    <investigator>
      <last_name>Daniel A. Morgenstern</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Montreal Children's Hospital of the MUHC</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3H 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>514-412-4445</phone>
      <email>info@thechildren.com</email>
    </contact>
    <investigator>
      <last_name>Sharon B. Abish</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Sainte-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>514-345-4931</phone>
      <email>yvan.samson@umontreal.ca</email>
    </contact>
    <investigator>
      <last_name>Monia Marzouki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke-Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>819-820-6480</phone>
      <email>crcinformation.chus@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Josee Brossard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>418-525-4444</phone>
    </contact>
    <investigator>
      <last_name>Bruno Michon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Starship Children's Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1145</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>0800 728 436</phone>
    </contact>
    <investigator>
      <last_name>Andrew C. Wood</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>03 364 0640</phone>
    </contact>
    <investigator>
      <last_name>Tristan Pettit</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HIMA San Pablo Oncologic Hospital</name>
      <address>
        <city>Caguas</city>
        <zip>00726</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>787-653-3434</phone>
    </contact>
    <investigator>
      <last_name>Jhon A. Guerra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>New Zealand</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eflornithine</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Camptothecin</mesh_term>
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Dinutuximab</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794349
org study id: ANBL1821
secondary id: NCI-2018-03377
secondary id: ANBL1821
secondary id: ANBL1821
secondary id: U10CA180886
nct id: NCT03794349
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab
      work with or without eflornithine in treating patients with neuroblastoma that has come back
      (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy,
      such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth
      of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping
      them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may
      induce changes in the body's immune system and may interfere with the ability of tumor cells
      to grow and spread. Eflornithine blocks the production of chemicals called polyamines that
      are important in the growth of cancer cells. Giving eflornithine with irinotecan
      hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with
      relapsed or refractory neuroblastoma.
PRIMARY OBJECTIVE:

      I. To determine whether administration of eflornithine hydrochloride (eflornithine [DFMO]) in
      combination with dinutuximab, irinotecan hydrochloride (irinotecan) and temozolomide results
      in an improved response rate compared to dinutuximab, irinotecan and temozolomide in patients
      with relapsed or refractory neuroblastoma and therefore is a therapeutic regimen worthy of
      further testing in patients with newly-diagnosed high-risk neuroblastoma.

      SECONDARY OBJECTIVES:

      I. To compare progression-free survival and overall survival between patients receiving
      dinutuximab, irinotecan and temozolomide with and without the addition of DFMO.

      II. To define the toxicity profile of DFMO administered with dinutuximab, irinotecan and
      temozolomide.

      EXPLORATORY OBJECTIVES:

      I. To characterize the immune and cytokine profiles of patients treated with
      DFMO/chemotherapy/dinutuximab combination and correlate with response to therapy.

      II. To evaluate GD2 levels in tumor cells from patient bone marrow samples and correlate with
      response to therapy.

      III. To explore whether the addition of DFMO to the dinutuximab and chemotherapy backbone
      affects pain as determined by patient report and opiate usage.

      OUTLINE: Patients are randomized to 1 of 2 regimens.

      REGIMEN A: Patients receive temozolomide orally (PO), via nasogastric (NG), or gastric (G)
      tube on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5,
      dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously (SC) or IV over
      2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in
      the absence of disease progression or unacceptable toxicity.

      REGIMEN B: Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21
      of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on
      days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5,
      dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days
      6-12. Treatment lasts 28 days for cycle 1 and then every 21 days for subsequent cycles up to
      6 cycles in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days and periodically for
      5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response rate
time frame: After every 2 cycles, for a maximum of 6 cycles of treatment
description: Responders are defined as patients who achieve a >= minor response (MR) per the International Neuroblastoma Response Criteria (INRC) as their best overall response by the end of 6 cycles. The response rate to treatment will be calculated among all eligible patients, including placement of a 95% confidence interval on the response rate.
measure: Progression-free survival (PFS)
time frame: Up to 5 years
description: Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up.
measure: Overall survival (OS)
time frame: Up to 5 years
description: Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.
measure: Incidence of adverse events >= Grade 3 (Regimen B)
time frame: Up to 5 years
description: The percentage of patients on Regimen B with at least one Grade 3 or higher toxicity will be calculated, assessed with Common Terminology Criteria for Adverse Events version 5.0.
measure: Immune and cytokine profiles
time frame: Up to 6 cycles
description: Will be assessed by exploring the relationship between response (responder versus [vs.] non-responder) after 6 cycles on Regimen B with serum cytokine levels (IL1, IL6, tumor necrosis factor [TNF]-alpha, IFN-gamma, etc.), tumor resident immune cells (natural killer [NK] cells, tumor-associated macrophages [TAMS], tumor infiltrating lymphocyte [TILS]), and critical immune cell suppressing proteins (B7H3, PDL-1) using Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous factors.
measure: GD2 levels in tumor cells from bone marrow samples
time frame: Up to 5 years
description: Will be correlated with response (responder vs. non-responder) after 6 cycles using Fisher's exact test for categorical and the Wilcoxon rank-sum test for continuous factors.
measure: Patient reported pain and opiate usage
time frame: Up to 5 years
description: The occurrence of pain on each regimen as reported by patient report and opiate use will be descriptively summarized. Descriptive and summary statistics will be used to describe the scores from the Faces Pain Scale-Revised during the dinutuximab infusion and on day 1 with irinotecan and temozolomide alone for each arm separately. Confidence intervals will be constructed for the mean and frequency estimates. The day 1 patient reported outcome data are expected to be similar between the 2 regimens, while differences during or after completion of treatment may be observed.
arm group label: Regimen A (chemotherapy, dinutuximab, sargramostim)
arm group type: Active Comparator
description: Patients receive temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
arm group label: Regimen B (eflornithine, chemotherapy, dinutuximab)
arm group type: Experimental
description: Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21 of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Treatment duration is 28 days for cycle 1 and then every 21 days in subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Dinutuximab
description: Given IV
arm group label: Regimen A (chemotherapy, dinutuximab, sargramostim)
arm group label: Regimen B (eflornithine, chemotherapy, dinutuximab)
other name: Ch 14.18UTC
other name: Ch14.18
other name: Dinutuximab Beta
other name: MOAB Ch14.18
other name: monoclonal antibody Ch14.18
other name: Qarziba
other name: Unituxin
intervention type: Drug
intervention name: Eflornithine Hydrochloride
description: Given PO or via NG or G tube
arm group label: Regimen B (eflornithine, chemotherapy, dinutuximab)
other name: alpha-Difluoromethylornithine hydrochloride
other name: Eflornithine.HCl
other name: MDL 71782
other name: Ornidyl
other name: RMI-71782
other name: Vaniqa
intervention type: Drug
intervention name: Irinotecan Hydrochloride
description: Given IV
arm group label: Regimen A (chemotherapy, dinutuximab, sargramostim)
arm group label: Regimen B (eflornithine, chemotherapy, dinutuximab)
other name: Campto
other name: Camptosar
other name: Camptothecin 11
other name: Camptothecin-11
other name: CPT 11
other name: CPT-11
other name: Irinomedac
other name: Irinotecan Hydrochloride Trihydrate
other name: Irinotecan Monohydrochloride Trihydrate
other name: U-101440E
intervention type: Biological
intervention name: Sargramostim
description: Given SC or IV
arm group label: Regimen A (chemotherapy, dinutuximab, sargramostim)
arm group label: Regimen B (eflornithine, chemotherapy, dinutuximab)
other name: 23-L-Leucinecolony-Stimulating Factor 2
other name: DRG-0012
other name: Leukine
other name: Prokine
other name: rhu GM-CFS
other name: Sagramostim
other name: Sargramostatin
intervention type: Drug
intervention name: Temozolomide
description: Given PO or via NG or G tube
arm group label: Regimen A (chemotherapy, dinutuximab, sargramostim)
arm group label: Regimen B (eflornithine, chemotherapy, dinutuximab)
other name: CCRG-81045
other name: Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
other name: M & B 39831
other name: M and B 39831
other name: Methazolastone
other name: RP-46161
other name: SCH 52365
other name: Temcad
other name: Temodal
other name: Temodar
other name: Temomedac
other name: TMZ
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Margaret E Macy
role: Principal Investigator
affiliation: Children's Oncology Group
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country: Australia
country: Canada
country: New Zealand
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Neuroblastoma
mesh term: Eflornithine
mesh term: Irinotecan
mesh term: Camptothecin
mesh term: Temozolomide
mesh term: Dinutuximab
mesh term: Sargramostim
mesh term: Antibodies, Monoclonal