A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
filgrastim
+ cisplatin
+ cyclophosphamide
Glioma+12
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: May 4, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy. Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation. Determine the toxic effects associated with this treatment in these patients. 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. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed central nervous system cancer including: Medulloblastoma with either local residual disease of greater than 1 cm^2 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 125,000/mm^3 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 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesOpen H. Lee Moffitt Cancer Center and Research Institute in Google MapsVeterans Affairs Medical Center - Lakeside Chicago
Chicago, United StatesRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesCCOP - Carle Cancer Center
Urbana, United States