For Healthcare Professionals

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

clipboard-pencil

About the study

Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE: To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma. To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

EXCLUSION CRITERIA

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of 1 of the following:


    1. Medulloblastoma
    2. Supratentorial primitive neuroectodermal tumor (PNET)
    3. PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma)
    4. Atypical teratoid rhabdoid tumor (ATRT)
    5. Definitive surgery for CNS tumor within the past 31 days

    Meets one of the following risk criteria:


    Average-risk disease


    Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI


    T4 disease eligible if all of the following are true:


    1. Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI
    2. Residual tumor or imaging abnormality whose size is < 1.5 cm^2
    3. No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery
    4. Brain stem invasion allowed in the absence of residual tumor (tumor < 1.5 cm^2 by imaging)

    High-risk disease meeting one of the following criteria:


    1. Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF)
    2. Presence of residual disease > 1.5 cm^2 at the primary site after surgery

    PATIENT CHARACTERISTICS:


    Age


    3 to 21 at diagnosis


    Performance status


    1. Lansky 30-100% (< 10 years old)
    2. Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome)

    Life expectancy


    Not specified


    Hematopoietic


    1. Hemoglobin > 8 g/dL
    2. WBC > 2,000/mm^3
    3. Absolute neutrophil count > 500/mm^3
    4. Platelet count > 50,000/mm^3

    Hepatic


    1. ALT < 5 times normal
    2. Bilirubin < 3.0 mg/dL

    Renal


    1. Creatinine < 2.0 mg/dL OR
    2. Creatinine clearance > 70 mL/min

    Other


    1. Not pregnant or nursing
    2. Negative pregnancy test
    3. Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:


    Biologic therapy


    Not specified


    Chemotherapy


    No prior chemotherapy


    Endocrine therapy


    Prior corticosteroid therapy allowed


    Radiotherapy


    No prior radiotherapy


    Surgery


    See Disease Characteristics


    pin location

    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Brain and Central Nervous System Tumors

    Age (in years)

    3 - 21

    Phase

    Phase 3

    Participants needed

    416

    Est. Completion Date

    Dec 31, 2023

    Treatment type

    Interventional


    Sponsor

    St. Jude Children's Research Hospital

    ClinicalTrials.gov identifier

    NCT00085202

    Study number

    SJMB03

    Understanding Clinical Trials


    Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
    Vector

    Interested?

    Sign up to save your favorites, 
    receive newsletters, resources, and alerts 
    about clinical trials related to your conditions of interest.