Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy Measurable disease by serial MRI or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 10 g/dL Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT and SGPT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: Resting oxygen saturation on room air at least 90% by pulse oximetry FVC, DLCO, and FEV_1 at least 50% of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious concurrent medical illness that would preclude study compliance No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior investigational biologics Chemotherapy: See Disease Characteristics No prior nitrosoureas for glioma No more than 1 prior chemotherapy regimen At least 4 weeks since prior chemotherapy No prior efaproxiral Endocrine therapy: Concurrent corticosteroids (e.g., dexamethasone) allowed Radiotherapy: See Disease Characteristics At least 90 days since prior radiotherapy Surgery: Not specified Other: At least 3 weeks since other prior investigational drugs or devices
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Winship Cancer Institute of Emory University
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital Cancer Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Wake Forest University Comprehensive Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- University of Texas Health Science Center at San Antonio