<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/NCT02212574</url>
  </required_header>
  <id_info>
    <org_study_id>J1403</org_study_id>
    <secondary_id>NA_00091840</secondary_id>
    <nct_id>NCT02212574</nct_id>
  </id_info>
  <brief_title>Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma</brief_title>
  <official_title>Pilot Study Assessing the Feasibility of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children With Wnt Positive Standard Risk Medulloblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Matthew Larson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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>
      Participants enrolling on this study will receive standard of care chemotherapy for Wnt&#xD;
      positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is&#xD;
      given during radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They&#xD;
      are referred to as A and B.&#xD;
&#xD;
      Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the&#xD;
      completion of two A cycles.&#xD;
&#xD;
      Below are the details of the drugs and schedules for A and B cycles.&#xD;
&#xD;
      Cycle A (This cycle lasts 42 days)&#xD;
&#xD;
        -  Lomustine (CCNU) is given by mouth on Day 1.&#xD;
&#xD;
        -  Vincristine is given directly into a vein (IV) over one minute or using a minibag over&#xD;
           several minutes by some institutions on Days 1, 8, and 15.&#xD;
&#xD;
        -  Cisplatin is given directly into a vein over 8 hours on Day 1&#xD;
&#xD;
      Cycle B (This cycle lasts 28 days)&#xD;
&#xD;
        -  Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.&#xD;
&#xD;
        -  MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given&#xD;
           15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.&#xD;
&#xD;
        -  Vincristine is given directly into a vein directly into the vein (IV) over one minute or&#xD;
           using a minibag over several minutes by some institutions on Days 1 and 8.&#xD;
&#xD;
      You may also get a supportive care drug called a myeloid growth factor (filgrastim or&#xD;
      pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is&#xD;
      given.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Participant relapses led to abrupt stop of study.&#xD;
  </why_stopped>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">November 9, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>3 years</time_frame>
    <description>To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patterns of Failure</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Medulloblastoma</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15. Cisplatin is given directly into a vein over 8 hours on Day 1. This cycle lasts 42 days.&#xD;
Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours. Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.This cycle lasts 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lomustine</intervention_name>
    <description>Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>CCNU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine</intervention_name>
    <description>Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Oncovin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Cisplatinum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Cytoxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesna</intervention_name>
    <description>Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Mesnex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine</intervention_name>
    <description>Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Oncovin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have classical histology posterior fossa medulloblastoma as&#xD;
             determined by institutional neuro-pathological evaluation.&#xD;
&#xD;
          -  Sufficient pathologic material must be available for central analysis and review&#xD;
&#xD;
          -  Tumors will be deemed Wnt positive if, at the time of central analysis, there is:&#xD;
&#xD;
          -  Monosomy 6 as determined by array CGH&#xD;
&#xD;
          -  Gene transcript detection by NanoString supporting Wnt+ medulloblastoma&#xD;
&#xD;
          -  Absence of large-cell, anaplastic histology&#xD;
&#xD;
          -  Nuclear b-catenin IHC will be determined, but not required for the diagnosis&#xD;
&#xD;
          -  Absence of residual or disseminated disease as defined by the following criteria:&#xD;
             Minimal residual disease as determined by post-operative imaging preferably performed&#xD;
             within 48 hours of resection (and at most 28 days post-surgery), i.e. gross total&#xD;
             resection or residual disease of &lt;1.5cm2 on post-operative imaging.&#xD;
&#xD;
        No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF).&#xD;
        Assessments must include MRI imaging of the brain and spine with and without contrast and a&#xD;
        lumbar puncture for CSF cytology&#xD;
&#xD;
          -  Diagnostic imaging (pre and post contrast) must be forwarded to Dana-Farber Cancer&#xD;
             Institute (DFCI) for central review to confirm eligibility&#xD;
&#xD;
          -  Patients must not have had any radiation therapy or chemotherapy for medulloblastoma&#xD;
             prior to study enrollment&#xD;
&#xD;
          -  Patients must have a Lansky performance status of &gt;/=30 for children &lt;/=10 years of&#xD;
             age or a Karnofsky performance status of &gt; 30 for children &gt; 10 years of age.&#xD;
&#xD;
          -  Participants must have normal organ and marrow function as defined below:&#xD;
&#xD;
          -  Hemoglobin greater than 10 g/dL (can be transfused). Hemoglobin &lt;10 g/dL due to&#xD;
             operative blood loss is permitted.&#xD;
&#xD;
          -  Absolute neutrophil count &gt; 1.0x109/L&#xD;
&#xD;
          -  Platelets &gt; 100,000/uL (non-transfused)&#xD;
&#xD;
          -  Total bilirubin &lt;1.5 x upper limit normal&#xD;
&#xD;
          -  SGOT (AST) or SGPT (ALT) &lt;2.5 x upper limit normal (ULN) for age&#xD;
&#xD;
          -  Creatinine clearance or radioisotope GFR &gt;70 ml/min/1.73m2 or normal serum creatinine&#xD;
             for patient's age and gender&#xD;
&#xD;
          -  All females of child-bearing age must have a negative pregnancy test before being&#xD;
             enrolled on study. All patients of child-bearing age must practice an effective method&#xD;
             of birth control whilst undergoing chemotherapy on study.&#xD;
&#xD;
          -  No history of allergic reactions attributed to compounds of similar chemical or&#xD;
             biologic composition to cisplatin, lomustine, vincristine or cyclophosphamide.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Cohen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Childrens Hospital Hematology/Oncology</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016-7710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado Center for Cancer &amp; Blood Disorders</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center-Orlando Pediatric Hematology/Oncology</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All Children's Hospital Pediatric Hematology/Oncology</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta- Egleston Pediatric Neuro-Oncology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann and Robert H Lurie Children's Hospital of Chicago Hematology/Oncology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine Pediatric Hematology/Oncology</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University Pediatric Hematology/Oncology</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239-3098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital Hematology/Oncology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Wisconsin (Medical College of Wisconsin)</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>October 8, 2021</results_first_submitted>
  <results_first_submitted_qc>October 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 5, 2021</results_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wnt</keyword>
  <keyword>Medulloblastoma</keyword>
  <keyword>Chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Medulloblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Lomustine</mesh_term>
    <mesh_term>Vincristine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02212574/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02212574/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02212574/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chemotherapy</title>
          <description>Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.&#xD;
Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15.&#xD;
Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.&#xD;
Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2.&#xD;
Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours.&#xD;
Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chemotherapy</title>
          <description>Chemo Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.&#xD;
Chemo Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide, repeated at 3 and 6 hours. Vincristine given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8. Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine: Chemo Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15.&#xD;
Cisplatin: Chemo Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.&#xD;
Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2.&#xD;
Mesna: Chemo Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide, repeated at 3 &amp; 6 hours.&#xD;
Vincristine: Chemo Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7" lower_limit="5" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival</title>
        <description>To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival.</description>
        <time_frame>3 years</time_frame>
        <population>This outcome was not assessed because some patients had a relapse and study was abruptly terminated.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.&#xD;
Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15.&#xD;
Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.&#xD;
Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2.&#xD;
Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours.&#xD;
Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival.</description>
          <population>This outcome was not assessed because some patients had a relapse and study was abruptly terminated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patterns of Failure</title>
        <description>To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival.</description>
        <time_frame>3 years</time_frame>
        <population>This outcome was not assessed because some patients had a relapse and study was abruptly terminated.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy</title>
            <description>Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.&#xD;
Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15.&#xD;
Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.&#xD;
Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2.&#xD;
Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours.&#xD;
Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Patterns of Failure</title>
          <description>To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival.</description>
          <population>This outcome was not assessed because some patients had a relapse and study was abruptly terminated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were not collected for standard of care chemotherapy.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.&#xD;
Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, &amp; 15.&#xD;
Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.&#xD;
Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 &amp; 2.&#xD;
Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 &amp; 6 hours.&#xD;
Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 &amp; 8.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Two of the participants relapsed not long into the study and the Data and Safety Management Committee (DSMC) recommended early closure of the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Kenneth Cohen</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>(410) 614-5055</phone>
      <email>kcohen@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02212574
org study id: J1403
secondary id: NA_00091840
nct id: NCT02212574
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Participants enrolling on this study will receive standard of care chemotherapy for Wnt
      positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is
      given during radiation therapy.
There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They
      are referred to as A and B.

      Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the
      completion of two A cycles.

      Below are the details of the drugs and schedules for A and B cycles.

      Cycle A (This cycle lasts 42 days)

        -  Lomustine (CCNU) is given by mouth on Day 1.

        -  Vincristine is given directly into a vein (IV) over one minute or using a minibag over
           several minutes by some institutions on Days 1, 8, and 15.

        -  Cisplatin is given directly into a vein over 8 hours on Day 1

      Cycle B (This cycle lasts 28 days)

        -  Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.

        -  MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given
           15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.

        -  Vincristine is given directly into a vein directly into the vein (IV) over one minute or
           using a minibag over several minutes by some institutions on Days 1 and 8.

      You may also get a supportive care drug called a myeloid growth factor (filgrastim or
      pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is
      given.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 3 years
description: To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival.
measure: Patterns of Failure
time frame: 3 years
description: To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival.
arm group label: Chemotherapy
arm group type: Other
description: Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15. Cisplatin is given directly into a vein over 8 hours on Day 1. This cycle lasts 42 days.
Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours. Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.This cycle lasts 28 days
intervention type: Drug
intervention name: Lomustine
description: Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.
arm group label: Chemotherapy
other name: CCNU
intervention type: Drug
intervention name: Vincristine
description: Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.
arm group label: Chemotherapy
other name: Oncovin
intervention type: Drug
intervention name: Cisplatin
description: Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.
arm group label: Chemotherapy
other name: Cisplatinum
intervention type: Drug
intervention name: Cyclophosphamide
description: Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.
arm group label: Chemotherapy
other name: Cytoxan
intervention type: Drug
intervention name: Mesna
description: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.
arm group label: Chemotherapy
other name: Mesnex
intervention type: Drug
intervention name: Vincristine
description: Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.
arm group label: Chemotherapy
other name: Oncovin
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Kenneth Cohen, MD
role: Study Chair
affiliation: Johns Hopkins University
facility: 
facility: 
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facility: 
country: United States
country: Canada
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Medulloblastoma
mesh term: Cyclophosphamide
mesh term: Lomustine
mesh term: Vincristine
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Two of the participants relapsed not long into the study and the Data and Safety Management Committee (DSMC) recommended early closure of the study.
point of contact: 