Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
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 anaplastic astrocytoma, adult mixed glioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following: Anaplastic astrocytoma Mixed oligodendroglial/astrocytic tumors Oligodendroglial component must be no greater than 25% No vascular proliferation and necrosis Increased cellularity, pleomorphism, and nuclear atypia allowed No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum) Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible Study therapy must begin within 6 weeks of diagnosis No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges Pathologic evidence of local meningeal infiltration by underlying tumor allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 1 year Hematopoietic: Hemoglobin at least 10 g/dL Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) Aspartate aminotransferase (AST) less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine less than 1.5 times normal Pulmonary: No pre-existing lung disease that, in the investigator's opinion, would preclude administration of carmustine or lomustine or completion of therapy Other: No other major medical illness or psychiatric impairment that would preclude study compliance No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No known hypersensitivity to 1 of the components of carmustine, lomustine, temozolomide, dacarbazine, or any other nitrosourea No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to brain or head and neck Surgery: Not specified Other: No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence is detected
Sites / Locations
- Mobile Infirmary Medical Center
- Arizona Oncology Services Foundation
- Enloe Cancer Center at Enloe Medical Center
- North Bay Cancer Center
- Solano Radiation Oncology Center
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
- University of Florida Shands Cancer Center
- Integrated Community Oncology Network
- Baptist Cancer Institute - Jacksonville
- Florida Oncology Associates at Southside Cancer Center
- Baptist Medical Center South
- Florida Oncology Associates
- Florida Cancer Center - Palatka
- Flagler Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- John B. Amos Cancer Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- OSF St. Francis Medical Center
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- McFarland Clinic, PC
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cotton-O'Neil Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Greenebaum Cancer Center at University of Maryland Medical Center
- West Michigan Cancer Center
- CCOP - Duluth
- St. John's Regional Health Center
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Methodist Cancer Center at Methodist Hospital - Omaha
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Lipson Cancer and Blood Center at Rochester General Hospital
- Mission Hospitals - Memorial Campus
- Akron City Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Case Comprehensive Cancer Center
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Cancer Treatment Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Allegheny Cancer Center at Allegheny General Hospital
- Reading Hospital and Medical Center
- Guthrie Cancer Center at Guthrie Clinic Sayre
- Rapid City Regional Hospital
- Latter Day Saints Hospital
- Theda Care Cancer Institute
- St. Vincent Hospital Regional Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Community Memorial Hospital Cancer Care Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
Radiation therapy + temozolomide (TMZ)
RT + BCNU/CCNU
Pilot Arm #1: RT+TMZ+BCNU
Pilot Arm #2: RT+TMZ+BCNU
Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles