Temozolomide and Radiation Therapy in Treating Patients With 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 diffuse astrocytoma, adult oligodendroglioma, adult mixed glioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed* supratentorial glioma of 1 of the following histologies: Astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic) Oligodendroglioma Oligoastrocytoma Note: *Histologic atypia allowed provided no other histologic features (i.e., frequent mitoses, endothelial proliferation, and/or acute necrosis) that would result in a designation of anaplastic astrocytoma, anaplastic mixed oligodendroglioma or oligoastrocytoma, or glioblastoma multiforme are present Unifocal or multifocal disease World Health Organization (WHO) grade II disease Neurofibromatosis allowed Surgical biopsy or resection for tumor tissue sampling required within the past 12 weeks Tissue block or core biopsy available for O6-methylguanine-DNA methyltransferase analysis and tissue banking Patients who have only had a stereotactic biopsy are not eligible Must have ≥ 3 of the following risk factors: Age 40 and over Largest preoperative tumor diameter ≥ 6 cm Tumor crosses the midline Astrocytoma-dominant tumor subtype Preoperative Neurological Function Status > 1 No other low-grade glioma histologies, including any of the following: Pilocytic astrocytoma Subependymal giant cell astrocytoma of tuberous sclerosis Subependymoma Pleomorphic xanthoastrocytoma Presence of a neuronal element, such as ganglioglioma Dysneuroembryoplastic epithelial tumor No high-grade glioma, including any of the following: Anaplastic astrocytoma Glioblastoma multiforme Anaplastic oligodendroglioma Anaplastic oligoastrocytoma No tumors in any non-supratentorial location, including any of the following: Optic chiasm Optic nerve(s) Pons Medulla Cerebellum Spinal cord No evidence of disease progression to spinal meninges or noncontiguous cranial meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal fluid (CSF) cytology MRI of the spine or CSF cytology are not required for patients without symptoms of spinal/cranial meningeal disease progression PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Total bilirubin ≤ 1.5 mg/dL Serum glutamate oxaloacetate transaminase (SGOT) or Serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal Alkaline phosphatase ≤ 2 times normal Renal Serum creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer No active infection PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy or biologic therapy Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the head and neck unless head and neck radiotherapy clearly excluded the brain (e.g., localized radiotherapy to the vocal cords) No prior radiotherapy to the brain No concurrent intensity modulated radiotherapy No concurrent stereotactic boost radiotherapy Surgery See Disease Characteristics Other No other concurrent investigational agents
Sites / Locations
- Arizona Oncology Services Foundation
- USC/Norris Comprehensive Cancer Center and Hospital
- CCOP - Christiana Care Health Services
- University of Florida Shands Cancer Center
- Integrated Community Oncology Network
- Baptist Cancer Institute - Jacksonville
- Integrated Community Oncology Network at Southside Cancer Center
- Mayo Clinic - Jacksonville
- Baptist Medical Center South
- Integrated Community Oncology Network - Orange Park
- Florida Cancer Center - Palatka
- Flagler Cancer Center
- University of Chicago Cancer Research Center
- DeCesaris Cancer Institute at Anne Arundel Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- University of Michigan Comprehensive Cancer Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- West Michigan Cancer Center
- Sparrow Regional Cancer Center
- Mayo Clinic Cancer Center
- CCOP - Kansas City
- Methodist Estabrook Cancer Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Roswell Park Cancer Institute
- Mission Hospitals - Memorial Campus
- Summa Center for Cancer Care at Akron City Hospital
- Aultman Cancer Center at Aultman Hospital
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Cancer Treatment Center
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Dixie Regional Medical Center - East Campus
- University Cancer Center at University of Washington Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Medical College of Wisconsin Cancer Center
- Hopital Notre-Dame du CHUM
- McGill Cancer Centre at McGill University
Arms of the Study
Arm 1
Experimental
Temozolomide + Radiation Therapy (RT)
Daily temozolomide plus concurrent radiotherapy followed by temozolomide