xml: <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/NCT05985161</url>
    </required_header>
    <id_info>
      <org_study_id>22-393</org_study_id>
      <nct_id>NCT05985161</nct_id>
    </id_info>
    <brief_title>A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors</brief_title>
    <official_title>A Multi-Center Phase II Study of Selinexor in Treating Recurrent or Refractory Wilms Tumor and Other Pediatric Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to find out whether selinexor is an effective treatment for&#xD;
        people under the age of 51 who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST,&#xD;
        or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes&#xD;
        that increase the activity of XP01.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2029</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Response Rate</measure>
      <time_frame>1 year</time_frame>
      <description>To define the antitumor activity of Selinexor in relapsed and refractory Wilms tumor by measuring the Overall Response Rate, defined as Complete Response + Partical Response</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Wilms Tumor</condition>
    <condition>Rhabdoid Tumor</condition>
    <condition>Malignant Peripheral Nerve Sheath Tumors</condition>
    <condition>MPNST</condition>
    <condition>Nephroblastoma</condition>
    <condition>XPO1 Gene Mutation</condition>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Cohort A.1 Wilms Tumor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have any type of Wilms tumor or nephroblastoma</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B.1 Rhabdoid Tumor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have any Rhabdoid tumor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort C.1 MPNST</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have progressive, relapsed, unresectable or metastatic MPNST</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort D.1 Other Solid Tumor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants must not qualify for Cohorts A, B, or C but have a solid tumor (no hematologic malignancies including lymphoma) for which there is specific evidence that this particular patient's tumor may benefit from selinexor.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Selinexor</intervention_name>
      <description>This phase II study will initially treat all patients, including adult patients, at the pediatric Selinexor RP2D of 35 mg/m2 (no maximum dose) once weekly using a liquid suspension .</description>
      <arm_group_label>Cohort A.1 Wilms Tumor</arm_group_label>
      <arm_group_label>Cohort B.1 Rhabdoid Tumor</arm_group_label>
      <arm_group_label>Cohort C.1 MPNST</arm_group_label>
      <arm_group_label>Cohort D.1 Other Solid Tumor</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age:&#xD;
  &#xD;
                 1. Age ≥ 6 at the time of informed consent&#xD;
  &#xD;
                 2. Age ≥ 2 years to &lt; 6 years at time of informed consent (Refer to Section 4.3): If&#xD;
                    PK cohort 1 is open, patients in this age range may enroll onto this cohort. If&#xD;
                    PK cohort 1 has been completed and deemed sufficient to proceed, then such&#xD;
                    patients may enroll onto the phase 2.&#xD;
  &#xD;
                 3. Age ≥ 12 months to &lt; 2 years at time of informed consent (Refer to Section 4.3):&#xD;
  &#xD;
          If PK cohort 2 is open, patients in this age range may enroll onto this cohort. If PK&#xD;
          cohort 2 has been completed and deemed sufficient to proceed, then such patients may enroll&#xD;
          onto the phase 2.&#xD;
  &#xD;
            -  Consent: All patients and/or their parents or legally authorized representatives must&#xD;
               sign a written informed consent. Assent, when appropriate, will be obtained according&#xD;
               to institutional guidelines.&#xD;
  &#xD;
            -  Performance: Karnofsky ≥ 60% for patients &gt; 16 years of age and Lansky ≥ 60 for&#xD;
               patients ≤ 16 years of age.&#xD;
  &#xD;
            -  Diagnosis: Patients must enroll into one of the following cohorts:&#xD;
  &#xD;
                 1. Cohort A: Any type of Wilms tumor or nephroblastoma is eligible for this study&#xD;
                    provided they meet at least one of these criteria: (1) in their second or greater&#xD;
                    relapse, (2) refractory or in their first relapse with high risk histology (i.e.,&#xD;
                    any anaplastic or blastemal-type after neoadjuvant chemotherapy), or (3)&#xD;
                    refractory or in first relapse without high risk histology but after having&#xD;
                    received chemotherapies other than the initial 4 agents used as current standard&#xD;
                    of care in the up-front setting for non-high risk cases - specifically&#xD;
                    vincristine, dactinomycin, doxorubicin, and irinotecan (i.e., any patient who&#xD;
                    relapses following an initial regimen more intense than EE4A, DD4A, VAD, AVD, or&#xD;
                    VIVA; for example, those including cyclophosphamide/etoposide - such as Regimen&#xD;
                    I, M, or MVI - or those additionally including carboplatin - such as Regimens&#xD;
                    UH-1, UH-2, or UH-3).&#xD;
  &#xD;
                 2. Cohort B: Any Rhabdoid tumor is eligible for this cohort. This includes, but is&#xD;
                    not limited to, related subtypes of rhabdoid tumors such as atypical teratoid&#xD;
                    rhabdoid tumors (ATRT), malignant rhabdoid tumors of the kidney (MRTK), malignant&#xD;
                    rhabdoid tumors of the soft tissue and liver, small cell undifferentiated&#xD;
                    hepatoblastomas (SCUH), and small-cell carcinoma of the ovary of hypercalcemic&#xD;
                    type (SCCOHT). Patients must have failed to respond to at least&#xD;
  &#xD;
                    1 line of systemic therapy prior to enrollment.&#xD;
  &#xD;
                 3. Cohort C: Patients with progressive, relapsed, unresectable or metastatic MPNST,&#xD;
                    are eligible for this cohort. Patients must have failed to respond to at least 1&#xD;
                    line of systemic therapy prior to enrollment.&#xD;
  &#xD;
                 4. Cohort D: Patients must not qualify for Cohorts A, B, or C but have a solid tumor&#xD;
                    (no hematologic malignancies including lymphoma) for which there is specific&#xD;
                    evidence that this particular patient's tumor may benefit from selinexor.&#xD;
  &#xD;
          Patients must have failed to respond to at least 1 line of systemic therapy prior to&#xD;
          enrollment. Examples of evidence are listed below. All patients in this cohort require&#xD;
          approval of study principal investigator and must provide documentation of specific&#xD;
          supporting evidence. i. Tumor XPO1 Dependency: Defined as either Darwin OncoTarget&#xD;
          demonstrating XPO1 as aberrantly activated or Darwin OncoTreat demonstrating&#xD;
          context-specific tumor checkpoint inversion with Selinexor, both of which must be&#xD;
          significant at a -log10 (Bonferroni corrected p-value) of 5 or greater. ii. Tumor XPO1&#xD;
          Activation: Defined as the detection of a gain of function mutation in XPO1, specifically&#xD;
          E571K. Additionally, detection of elevated transcriptomic or proteomic expression of XPO1&#xD;
          in the tumor via RNAseq or IHC, respectively, would be considered sufficient for treatment.&#xD;
          iii. Preclinical Tumor Testing: Defined as testing of Selinexor on patient derived cell&#xD;
          line, organoid, or xenograft models of the patient's tumor (or other related tumors)&#xD;
          performed in a laboratory context and for which, in the investigator's opinion,&#xD;
          demonstrates promising activity. Testing may include commercial testing as well as academic&#xD;
          laboratory testing.&#xD;
  &#xD;
            -  Disease Status: Patients on the phase II portion of the study must have measurable&#xD;
               disease whereas patients on the PK cohorts can have either evaluable or measurable&#xD;
               disease as measured by the revised Response Evaluation Criteria in Solid Tumors&#xD;
               (RECIST) guideline (Version 1.1).&#xD;
  &#xD;
               a. Primary Brain Tumors: Patients with primary brain tumors are eligible and must also&#xD;
               have measurable disease for the phase II (as well as evaluable or measurable for the&#xD;
               PK cohorts), but this can be defined as at least equal or greater than twice the slice&#xD;
               thickness in two perpendicular diameters on MRI OR diffuse leptomeningeal disease OR&#xD;
               clear MRI evidence of disease that may not be measurable in two perpendicular&#xD;
               diameters OR positive CSF cytology alone.&#xD;
  &#xD;
            -  Prior Therapy: Patients must have fully recovered from the acute toxic effects of all&#xD;
               prior anti-cancer therapy and meet minimum washout durations (shown below) from prior&#xD;
               therapy.&#xD;
  &#xD;
                 1. Anti-cancer agents not known to be myelosuppressive: ≥ 7 days&#xD;
  &#xD;
                 2. Anti-cancer and cytotoxic agents known to be myelosuppressive: ≥ 21 days&#xD;
  &#xD;
                 3. Immunotherapies (including antibodies, interleukins, interferons, etc.): ≥ 21&#xD;
                    days&#xD;
  &#xD;
                 4. Adoptive cellular therapies (including modified T cells, vaccines, etc.): ≥ 42&#xD;
                    days&#xD;
  &#xD;
                 5. Autologous stem cell infusion (boost, no conditioning): ≥ 21 days&#xD;
  &#xD;
                 6. Autologous stem cell transplantation (with conditioning): ≥ 42 days&#xD;
  &#xD;
                 7. Allogeneic bone marrow transplantation: ≥ 84 days&#xD;
  &#xD;
                 8. Focal external beam radiation (e.g., limited sites of disease): ≥ 14 days&#xD;
  &#xD;
                 9. Substantial external beam radiation (e.g. whole lung or abdomen): ≥ 42 days&#xD;
  &#xD;
                10. Radiopharmaceutical therapy (e.g., radiolabeled antibody or MIBG): ≥ 42 days&#xD;
  &#xD;
            -  Hepatic Function: Adequate function (within 14 days prior to C1D1), defined as:&#xD;
  &#xD;
                 1. Total bilirubin &lt; 1.5 × upper limit of normal (ULN) (except patients with&#xD;
                    Gilbert's syndrome, who must have a total bilirubin of &lt;3 × ULN)&#xD;
  &#xD;
                 2. Alanine aminotransferase (ALT) &lt; 3 × ULN&#xD;
  &#xD;
                 3. Serum albumin ≥ 2 g/dL&#xD;
  &#xD;
            -  Renal Function: Adequate function (within 14 days prior to C1D1) defined as a GFR&#xD;
  &#xD;
               ≥ 50 ml/min/1.73 m2 determined via any of these methods:&#xD;
  &#xD;
                 1. Nuclear radioisotope&#xD;
  &#xD;
                 2. 24 hr urine creatinine clearance&#xD;
  &#xD;
                 3. Serum cystatin c&#xD;
  &#xD;
                 4. Serum creatinine using the Schwartz formula for estimating creatinine clearance&#xD;
                    (Schwartz et al. J Peds, 106:522, 1985)&#xD;
  &#xD;
            -  Hematologic Function: Adequate function (within 14 days prior to C1D1), defined as:&#xD;
  &#xD;
                 1. Absolute neutrophil count (ANC) ≥ 1000/mm3&#xD;
  &#xD;
                 2. Platelet count ≥ 100,000/mm3&#xD;
  &#xD;
                 3. Note: patients may not receive platelet transfusions nor hematopoietic growth&#xD;
                    factor support, including granulocyte-colony stimulating factor (e.g. filgrastim)&#xD;
                    and platelet stimulators (e.g. romiplostim) for at least 7 days prior to&#xD;
                    demonstrating adequate hematologic function.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior Therapy: Has received selinexor or another XPO1 inhibitor previously.&#xD;
  &#xD;
            -  Infection: Patients who have an uncontrolled infection are not eligible. Patients on&#xD;
               prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1&#xD;
               are acceptable&#xD;
  &#xD;
            -  Transplants: Patients who have received allogeneic bone marrow transplant are&#xD;
               potentially eligible unless they are being actively treated for GvHD. Patients who&#xD;
               have had a prior solid organ transplantation are not eligible.&#xD;
  &#xD;
            -  Compliance: Patients who as a result of serious medical, psychiatric, and/or social&#xD;
               situation(s), in the opinion of the investigator, may not be able to comply with&#xD;
               supportive care, safety monitoring, or any other key requirements of the study&#xD;
               protocols are not eligible.&#xD;
  &#xD;
            -  Pregnancy and Breast-feeding: Pregnant or breast-feeding women will not be entered on&#xD;
               this study because there is yet no available information regarding human fetal or&#xD;
               teratogenic toxicities. Pregnancy tests must be obtained in girls who are&#xD;
               post-menarchal.&#xD;
  &#xD;
            -  Contraception: Males or females of reproductive potential may not participate unless&#xD;
               they have agreed to use two effective methods of birth control, including a medically&#xD;
               accepted barrier or contraceptive method (e.g., male or female condom) for the&#xD;
               duration of the study. Abstinence is an acceptable method of birth control.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Ortiz, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael Ortiz, MD</last_name>
      <phone>1-833-MSK-KIDS</phone>
      <email>ortizm2@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julia Glade Bender, MD</last_name>
      <phone>1-833-MSK-KIDS</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital of Los Angeles (Data Collection Only)</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90027</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Rachana Shah, MD</last_name>
        <phone>323-660-2450</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Children's Healthcare of Atlanta (Data Collection and Specimen Analysis)</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Thomas Cash, MD</last_name>
        <phone>404-785-0910</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dana Farber Cancer Institute (Data Collection Only)</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Elizabeth Mullen, MD</last_name>
        <phone>617-632-1938</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (Limited protocol activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All protocol activites)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Limited protocol activities)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Ortiz, MD</last_name>
        <phone>833-675-5437</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cincinnati Children's Hospital Medical Center (Data collection only)</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>James Geller, MD</last_name>
        <phone>513-517-2234</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Wilms Tumor</keyword>
    <keyword>Rhabdoid Tumor</keyword>
    <keyword>Malignant Peripheral Nerve Sheath Tumors</keyword>
    <keyword>MPNST</keyword>
    <keyword>Nephroblastoma</keyword>
    <keyword>XPO1</keyword>
    <keyword>Selinexor</keyword>
    <keyword>Memorial Sloan Kettering Cancer Center</keyword>
    <keyword>22-393</keyword>
    <keyword>Solid Tumor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Wilms Tumor</mesh_term>
      <mesh_term>Rhabdoid Tumor</mesh_term>
      <mesh_term>Nerve Sheath Neoplasms</mesh_term>
      <mesh_term>Neurofibrosarcoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985161
  org study id: 22-393
  nct id: NCT05985161
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to find out whether selinexor is an effective treatment for
        people under the age of 51 who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST,
        or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes
        that increase the activity of XP01.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall Response Rate
  time frame: 1 year
  description: To define the antitumor activity of Selinexor in relapsed and refractory Wilms tumor by measuring the Overall Response Rate, defined as Complete Response + Partical Response
  arm group label: Cohort A.1 Wilms Tumor
  arm group type: Experimental
  description: Participants will have any type of Wilms tumor or nephroblastoma
  arm group label: Cohort B.1 Rhabdoid Tumor
  arm group type: Experimental
  description: Participants will have any Rhabdoid tumor
  arm group label: Cohort C.1 MPNST
  arm group type: Experimental
  description: Participants will have progressive, relapsed, unresectable or metastatic MPNST
  arm group label: Cohort D.1 Other Solid Tumor
  arm group type: Experimental
  description: Participants must not qualify for Cohorts A, B, or C but have a solid tumor (no hematologic malignancies including lymphoma) for which there is specific evidence that this particular patient's tumor may benefit from selinexor.
  intervention type: Drug
  intervention name: Selinexor
  description: This phase II study will initially treat all patients, including adult patients, at the pediatric Selinexor RP2D of 35 mg/m2 (no maximum dose) once weekly using a liquid suspension .
  arm group label: Cohort A.1 Wilms Tumor
  arm group label: Cohort B.1 Rhabdoid Tumor
  arm group label: Cohort C.1 MPNST
  arm group label: Cohort D.1 Other Solid Tumor
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: N/A
  healthy volunteers: No
  last name: Michael Ortiz, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Michael Ortiz, MD
  phone: 1-833-MSK-KIDS
  email: ortizm2@mskcc.org
  last name: Julia Glade Bender, MD
  phone: 1-833-MSK-KIDS
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Wilms Tumor
  mesh term: Rhabdoid Tumor
  mesh term: Nerve Sheath Neoplasms
  mesh term: Neurofibrosarcoma
  sharing ipd: Yes
  ipd description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.