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Combination chemotherapy followed by peripheral stem cell transplant in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma

eagle-i ID


Resource Type

  1. Clinical trial


  1. ClinicalTrials.gov url
  2. Intervention
    Antineoplastic combined chemotherapy
  3. Intervention
  4. Resource Description
    Supratentorial PNETs and High Risk Medulloblastoma’s that occur in children less than 36 months age at diagnosis are fast growing brain tumors that if not treated are always fatal. Treatment for these tumors usually involves surgery to remove as much of the tumor as possible followed by chemotherapy (anti-cancer drug therapy) and sometimes radiation. Many of these tumors do go away with the treatment but may come back once treatment has stopped. The goal of this study is to find a treatment which will kill the tumor cells that remain after surgery and hopefully cure the child. At this time there is no known standard proven treatment for these tumors but two small experimental research studies have treated children less than 36 months with induction chemotherapy followed with intense chemotherapy and stem cell rescue with some tumors responding to the treatments. These two studies used the same chemotherapy drugs but the second study added methotrexate during the induction period. The purpose of this study is to compare the two experimental treatment regimens to see if one is better for children with high risk medulloblastoma or supratentorial PNET. Subjects will receive one of two different treatment plans.Subjects will be assigned to either Arm A, which is the 4 drug induction chemotherapy, or Arm B, which is the same 4 drug induction chemotherapy as in Arm A with the addition of methotrexate. The difference in the regimens is the addition of the drug methotrexate to the induction therapy to determine if adding the drug will prove more effective in treating the tumor. After the induction the two arms of the study are the same. If the tumor goes away with the induction therapy, the subjects will have 3 cycles of consolidation chemotherapy followed by stem cell rescue. If the tumor has gotten smaller, but is not completely gone or does not change size after induction chemotherapy, subjects may have another surgery to remove the rest of the tumor. Once recovered from surgery, subjects will have 3 cycles of consolidation chemotherapy followed by stem cell rescue. Another goal of this study is to do research tests on some of the tumor tissue that is taken out during surgery. These tests are being done to better understand things about the tumor cells such as the kinds of proteins in them and if they have any genetic differences. In addition some blood may need to be collected for these tests.
  5. Additional Name
    Phase III randomized trial for the treatment of newly diagnosed supratentorial PNET and high risk medulloblastoma in children <36 months old with intensive induction chemotherapy with methotrexate followed by consolidation with stem cell rescue versus the same therapy without methotrexate
  6. Contact
    Berenberg, Jeffrey
  7. PI
    Wilkinson, Robert, M.D.
  8. Topic
  9. Topic
    cerebral primitive neuroectodermal tumor
  10. Study Population
    Males and females under three years old with diagnosis of high-risk medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET) (any M-stage), anaplastic medulloblastoma regardless of M-stage or residual tumor, or M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically measurable residual disease < 1.5 cm^2.
  11. Website(s)
  12. Funded by
    Children's Oncology Group
  13. Phase
    Phase 3 clinical trial
  14. Performed by
    Clinical Protocol & Data Management Shared Resource
Provenance Metadata About This Resource Record
  1. workflow state
  2. contributor
  3. created
  4. creator
    awendicke (Annemarie Wendicke)
  5. modified
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