Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed 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 adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision No gliomas graded less than glioblastoma multiforme No recurrent malignant gliomas No tumor foci below the tentorium or beyond the cranial vault Study therapy must begin ≤ 5 weeks after surgery PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy At least 8 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL* Hematocrit ≥ 30%* NOTE: *Transfusion allowed Hepatic Bilirubin ≤ 0.5 mg/dL ALT or AST ≤ 2 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL BUN ≤ 25 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception during and for 2 months after study participation No AIDS No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent sargramostim (GM-CSF) Chemotherapy No other concurrent chemotherapy Endocrine therapy Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry Radiotherapy No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields Prior radiotherapy for stage T1 glottic cancer allowed Surgery See Disease Characteristics Recovered from prior surgery Other No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan Concurrent non-enzyme-inducing antiepileptic drugs allowed
Sites / Locations
- Foundation for Cancer Research and Education
- Providence Saint Joseph Medical Center - Burbank
- Saint Agnes Medical Center
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Providence Holy Cross Cancer Center
- Pomona Valley Hospital Medical Center
- Radiological Associates of Sacramento Medical Group, Inc.
- Yale Comprehensive Cancer Center at Yale University School of Medicine
- CCOP - Christiana Care Health Services
- University of Florida Shands Cancer Center
- Baptist Cancer Institute - Jacksonville
- John B. Amos Community Cancer Center
- Regional Radiation Oncology Center at Rome
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Northwest Community Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- University of Chicago Cancer Research Center
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- St. Francis Hospital and Health Centers
- Tulane Cancer Center
- CCOP - Ochsner
- University of Michigan Comprehensive Cancer Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- West Michigan Cancer Center
- Regional Cancer Center at Singing River Hospital
- Cancer Institute of Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Siteman Cancer Center at Barnes-Jewish Hospital
- Methodist Cancer Center at Methodist Hospital - Omaha
- CCOP - Southern Nevada Cancer Research Foundation
- Dartmouth - Hitchcock Concord
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Institute of New Jersey at the Cooper University Hospital
- Cooper Cancer Institute
- John F. Kennedy Medical Center
- Monmouth Medical Center
- Community Medical Center
- University of New Mexico Cancer Research and Treatment Center
- Roswell Park Cancer Institute
- Lipson Cancer and Blood Center at Rochester General Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
- Wayne Radiation Oncology
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Annie Penn Cancer Center
- Akron City Hospital
- McDowell Cancer Center at Akron General Medical Center
- Radiation Oncology Center
- Aultman Hospital Cancer Center at Aultman Health Foundation
- Charles M. Barrett Cancer Center at University Hospital
- CCOP - Columbus
- Grandview Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Veterans Affairs Medical Center - Dayton
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cancer Treatment Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
- St. Luke's Hospital Cancer Center
- Bryn Mawr Hospital
- UPMC Cancer Center - Arnold Palmer Pavilion
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- UPMC McKeesport
- Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Albert Einstein Cancer Center
- Allegheny Cancer Center at Allegheny General Hospital
- UPMC Cancer Center at Magee-Womens Hospital
- UPMC Cancer Center at UPMC Presbyterian
- UPMC St. Margaret
- Mercy Hospital of Pittsburgh
- UPMC - Shadyside
- UPMC - Passavant Hospital
- Cancer Center at St. Clair Memorial Hospital
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Reading Hospital and Medical Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- York Cancer Center at Wellspan Health
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Dixie Regional Medical Center
- Green Mountain Oncology Group
- Fletcher Allen Health Care - University Health Center Campus
- Community Cancer Center at Rutland Regional Medical Center
- Massey Cancer Center at Virginia Commonwealth University
- CCOP - Virginia Mason Research Center
- Southwest Washington Medical Center Cancer Center
- North Star Lodge Cancer Center
- St. Vincent Hospital
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- University of Wisconsin Comprehensive Cancer Center
- Community Memorial Hospital
- Medical College of Wisconsin Cancer Center
Arms of the Study
Arm 1
Experimental
RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy