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A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma (NCT00003573)

National Cancer Institute (NCI)
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.
  • Biological: filgrastim
    • Granulocyte Colony-Stimulating Factor
    • r-metHuG-CSF
    • G-CSF
    • Neupogen®
    • NSC #614629
  • Drug: cisplatin
    • Cis-diamminedichloroplatinum II
    • CDDP
    • Platinol
    • NSC #119875
  • Drug: cyclophosphamide
    • CTX
    • Cytoxan
    • NSC #026271
    • IND #7089
  • Drug: etoposide
    • VP-16
    • VePesid
    • NSC #141540
    • IND #9197
  • Drug: vincristine sulfate
    • VCR
    • Oncovin
    • NSC #067574
    • IND #7161
  • Radiation: radiation therapy
    Ages eligible for Study
    3 Years to 21 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    106 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 October, 1998
    Updated:
    23 July, 2014
    Participants:
    53
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