Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Ependymoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use 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 more than one drug or combining chemotherapy with radiation therapy may kill more
      tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      radiation therapy in treating patients who have surgically resected, newly diagnosed
      medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected
      ependymoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin,
           vincristine, cyclophosphamide, and etoposide with or without methotrexate followed by
           standard radiotherapy in patients with surgically resected, newly diagnosed high stage
           medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely
           resected ependymoma.

        -  Determine the response rate, time to progression, overall survival, and pattern of
           failure in these patients treated with this regimen.

      OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV
      over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and
      cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of
      dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3.
      Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing
      until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses
      in the absence of disease progression or unacceptable toxicity. Patients then undergo
      radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of
      chemotherapy.

      Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year,
      every 6 months for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.
    

Intervention name(s): filgrastim; cisplatin; cyclophosphamide; etoposide; methotrexate; vincristine sulfate; adjuvant therapy; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Methotrexate; Etoposide; Vincristine
Primary purpose: Treatment
Keywords: childhood infratentorial ependymoma; childhood supratentorial ependymoma; adult medulloblastoma; adult myxopapillary ependymoma; adult anaplastic ependymoma; adult ependymoblastoma; untreated childhood supratentorial primitive neuroectodermal tumor; untreated childhood medulloblastoma; newly diagnosed childhood ependymoma; adult supratentorial primitive neuroectodermal tumor (PNET)