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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

Phase 2
3 Years
21 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


- 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

Inclusion Criteria


- Histologically diagnosed advanced (high grade) childhood medulloblastoma

- Residual disease of at least 1.5 cm2 in size on MRI or CT scan OR

- Evidence of CNS or extraneural metastases



- 3 to 21

Performance status:

- Not specified

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- SGPT less than 5 times normal

- Bilirubin less than 1.5 mg/dL


- Creatinine less than 1.7 mg/dL OR

- Creatinine clearance greater than 70 mL/min


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed


- No prior radiotherapy


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Albert Moghrabi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Sainte Justine


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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