Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
Condition: Brain Tumors; Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma
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 radiation therapy with chemotherapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy
      followed by combination chemotherapy in treating children with newly diagnosed advanced
      medulloblastoma.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the response rate and toxicity of oral etoposide and radiotherapy in children
           with newly diagnosed high stage medulloblastoma.

        -  Compare the response rate and toxicity of these patients to historical control patients
           registered on POG #9031.

        -  Estimate the 2-year event-free survival and overall survival of these patients.

        -  Evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin,
           cyclophosphamide, and vincristine following craniospinal irradiation in these patients.

      OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of
      radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of
      metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks
      concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).

      Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for
      3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses
      (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily
      for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1,
      8, and 15 every 4 weeks for 8 courses (weeks 23-51).

      Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
      for 1 year, and annually thereafter.

      PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2
      years.
    

Intervention name(s): filgrastim; cisplatin; cyclophosphamide; etoposide; vincristine sulfate; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Radiation
Other intervention name(s): Granulocyte Colony-Stimulating Factor; r-metHuG-CSF; G-CSF; Neupogen®; NSC #614629; Cis-diamminedichloroplatinum II; CDDP; Platinol; NSC #119875; CTX; Cytoxan; NSC #026271; IND #7089; VP-16; VePesid; NSC #141540; IND #9197; VCR; Oncovin; NSC #067574; IND #7161
Intervention MeSH terms: Cyclophosphamide; Cisplatin; Etoposide; Vincristine; Lenograstim
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated childhood medulloblastoma