Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	ECOG-4397 SWOG-E4397, NCT00003309, E4397

Objectives

1. Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy.
2. Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation.
3. Determine the toxic effects associated with this treatment in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed central nervous system cancer including:
  • Medulloblastoma with either local residual disease of greater than 1 cm² on MRI following resection or evidence of metastases (M1-4)
  • Other primitive neuroectodermal tumors
  • Ependymoma with evidence of subarachnoid metastases



• Must have less than 1 cm of midline shift or no acute elevated intercranial pressure

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No increasing doses of steroids for intracranial disease within 3 days of registration

Radiotherapy:

• No prior radiotherapy

Surgery:

• 10-28 days since prior surgical resection

  OR

• At least 5 days since prior biopsy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm³
• Platelet count greater than 125,000/mm³
• Hemoglobin greater than 10 g/dL
• No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)
• SGOT less than 2 times ULN
• Alkaline phosphatase less than 2 times ULN
• No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Renal:

• Creatinine greater than 70 mL/min
• No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Pulmonary:

• No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted
• No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Other:

• No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up
• No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 33 patients will be accrued for this study within 3 years.

Outline

Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.

Moots PL, O'Neill A, Barger GR, et al.: Toxicities associated with chemotherapy followed by craniospinal radiation for adults with poor-risk medulloblastoma/PNET and disseminated ependymoma: a preliminary report of ECOG 4397. [Abstract] J Clin Oncol 22 (Suppl 14): A-1573, 125s, 2004.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Paul Moots, MD, Protocol chair		Ph: 615-936-021; 800-811-8480 Email: paul.moots@vanderbilt.edu
Larry Kleinberg, MD, Protocol co-chair		Ph: 410-614-2497 Email: kleinla@jhmi.edu

Southwest Oncology Group

Geoffrey Barger, MD, Protocol chair		Ph: 313-577-1243; 800-527-6266 Email: gbarger@med.wayne.edu

Registry Information
Official Title		A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults with "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
Trial Start Date		1998-07-23
Trial Completion Date		2008-03-10
Registered in ClinicalTrials.gov		NCT00003309
Date Submitted to PDQ		1998-05-06
Information Last Verified		2004-09-08
NCI Grant/Contract Number		U10-CA21115

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