SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
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 recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven refractory or recurrent supratentorial glioblastoma multiforme Bidimensionally measurable, enhancing residual disease by T1-weighted gadolinium-enhanced MRI required within 15 days prior to treatment Stable dose of corticosteroids required for at least 7 days prior to scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL without blood transfusions for 15 days prior to treatment Hepatic: AST/SGOT no greater than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 40 mL/min Other: Not allergic to etoposide Effective contraception required of fertile patients Negative serum pregnancy test required of fertile women No other acute or chronic medical or psychiatric condition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior leflunomide (SU101) therapy No more than one prior single-agent or combination systemic chemotherapy regimen for initial disease Radiosensitizer(s) concurrent with radiotherapy allowed in addition to chemotherapy for primary disease At least 6 weeks since nitrosourea or mitomycin At least 2 weeks since vincristine No prior single-agent procarbazine At least 4 weeks since other chemotherapy No concurrent chemotherapy agents Endocrine therapy: No concurrent hormone therapy (except medroxyprogesterone acetate for appetite stimulation) Less than 4 weeks of prior hormonal therapy (tamoxifen or retinoids) if failed one prior chemotherapy regimen Radiotherapy: Prior conventional radiotherapy for initial disease required No more than one prior course of radiotherapy At least 8 weeks since radiotherapy No prior interstitial radiotherapy No concurrent radiotherapy Surgery: Maximally feasible resection for initial disease required No more than two resections permitted At least 1 week since surgery and/or biopsy for disease No prior interstitial radiotherapy or implanted BCNU-wafers No concurrent surgery (including resection, stereotactic surgery or interstitial implants) Other: No concurrent investigational agent At least 4 weeks since prior investigational agent At least 1 week since cholestyramine or monoamine oxidase inhibitors
Sites / Locations
- St. Joseph's Hospital and Medical Center
- Arizona Cancer Center
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Beckman Research Institute, City of Hope
- St. Francis Hospital
- University of Colorado Cancer Center
- Mount Sinai Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Medical College of Georgia Hospital and Clinics
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Indiana University Cancer Center
- University of Iowa College of Medicine
- Beth Israel Deaconess Medical Center
- University of Massachusetts Memorial Medical Center
- University of Michigan Comprehensive Cancer Center
- Henry Ford Hospital
- University of Nebraska Medical Center
- Cancer Center of Albany Medical Center
- Albert Einstein Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center
- Lineberger Comprehensive Cancer Center, UNC
- Barrett Cancer Center, The University Hospital
- Arthur G. James Cancer Hospital - Ohio State University
- Western Pennsylvania Cancer Institute
- Rhode Island Hospital
- Vanderbilt Cancer Center
- Simmons Cancer Center - Dallas
- University of Texas - MD Anderson Cancer Center
- University of Washington Medical Center
- Medical College of Wisconsin
- Cross Cancer Institute
- Cancer Care Ontario-London Regional Cancer Centre
- Princess Margaret Hospital