Clinical Trials /

Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma

NCT02212574

Description:

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.

Related Conditions:
  • Medulloblastoma
Recruiting Status:

Suspended

Phase:

N/A

Trial Eligibility

Document

Study Assessing the Feasibility of a Surgery and <span class="go-doc-concept go-doc-intervention">Chemotherapy</span>-Only in Children With Wnt Positive <span class="go-doc-concept go-doc-disease">Medulloblastoma</span>

Title

  • Brief Title: Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02212574

    ORG ID: J1403

    NCI ID: NA_00091840

    Trial Conditions

    Medulloblastoma

    Trial Interventions

    Drug Synonyms Arms
    Lomustine CCNU Chemotherapy
    Vincristine Oncovin Chemotherapy
    Cisplatin Cisplatinum Chemotherapy
    Cyclophosphamide Cytoxan Chemotherapy
    Mesna Mesnex Chemotherapy
    Vincristine Oncovin Chemotherapy

    Trial Purpose

    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.

    Detailed Description

    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.

    Trial Arms

    Name Type Description Interventions
    Chemotherapy Other 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 Lomustine, Vincristine, Cisplatin, Cyclophosphamide, Mesna, Vincristine

    Eligibility Criteria

    Inclusion Criteria:

    - Participants must have classical histology posterior fossa medulloblastoma as
    determined by institutional neuro-pathological evaluation.

    - Institutional beta- catenin staining must demonstrate nuclear reactivity by
    immunohistochemistry

    - Sufficient pathologic material must be available for central analysis and review

    - Tumors will be deemed Wnt positive if, at the time of central analysis, there is:

    - Confirmation of beta-catenin nuclear reactivity by immunohistochemistry.

    - Monosomy 6 as determined by array CGH

    - Absence of MYCN or MYC amplification (as determined by FISH)

    - Absence of large-cell, anaplastic histology

    - Absence of residual or disseminated disease as defined by the following criteria:
    Minimal residual disease as determined by post-operative imaging preferably performed
    within 48 hours of resection (and at most 28 days post-surgery), i.e. gross total
    resection or residual disease of <1.5cm2 on post-operative imaging.

    No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF).
    Assessments must include MRI imaging of the brain and spine with and without contrast and
    a lumbar puncture for CSF cytology

    - Patients must not have had any radiation therapy or chemotherapy for medulloblastoma
    prior to study enrollment

    - Patients must have a Lansky performance status of >/=30 for children </=10 years of
    age or a Karnofsky performance status of > 30 for children > 10 years of age.

    - Participants must have normal organ and marrow function as defined below:

    - Hemoglobin greater than 10 g/dL (can be transfused). Hemoglobin <10 g/dL due to
    operative blood loss is permitted.

    - Absolute neutrophil count > 1.0x109/L

    - Platelets > 100,000/uL (non-transfused)

    - Total bilirubin <1.5 x upper limit normal

    - SGOT (AST) or SGPT (ALT) <2.5 x upper limit normal (ULN) for age

    - Creatinine clearance or radioisotope GFR >70 ml/min/1.73m2 or normal serum creatinine
    for patient's age and gender

    - All females of child-bearing age must have a negative pregnancy test before being
    enrolled on study. All patients of child-bearing age must practice an effective
    method of birth control whilst undergoing chemotherapy on study.

    - No history of allergic reactions attributed to compounds of similar chemical or
    biologic composition to cisplatin, lomustine, vincristine or cyclophosphamide.

    Minimum Eligible Age: 3 Years

    Maximum Eligible Age: 18 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Patterns of Failure

    Trial Keywords

    Wnt

    Medulloblastoma

    Chemotherapy