Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma Newly diagnosed by surgical biopsy or excision within the past 5 weeks Supratentorial location, as determined by the following: Contrast-enhanced MRI performed preoperatively MRI performed postoperatively within 28 days prior to study entry (preferably within 72 hours of surgery) Postoperative scan not required if diagnosed by stereotactic biopsy and pre-operative MRI was performed No gliomas graded < GBM No recurrent malignant gliomas No tumor foci detected below the tentorium or beyond the cranial vault No multifocal disease or leptomeningeal spread Zubrod performance status 0-1 Neurologic function status 0-2 Absolute neutrophil count ≥ 1,800 cells/mm^3 Platelet count ≥ 100,000 cells/mm^3 Hemoglobin ≥ 8 g/dL (transfusion allowed) BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL Bilirubin ≤ 1.5 mg/dL ALT or AST ≤ 2 times upper limit of normal Fertile patients must use effective contraception during and for 2 months after completion of study treatment Negative pregnancy test Not pregnant or nursing No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ? 3 years No severe, active comorbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at study entry Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry Coagulation defects Known AIDS No prior allergic reaction to the study drugs No history of porphyria or G6PD deficiency No allergy to gadolinium or contraindications to MRI No other concurrent chemotherapy Recovered from effects of surgery or postoperative infection and other complications No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant (Gliadel wafer), for the current GBM Prior chemotherapy for a different cancer allowed No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields No prophylactic filgrastim (G-CSF) during the first course of study treatment No concurrent sargramostim (GM-CSF)
Sites / Locations
- Mobile Infirmary Medical Center
- Arizona Oncology Services Foundation
- The University of Arizona Medical Center-University Campus
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Bay Area Breast Surgeons Inc
- Valley Medical Oncology Consultants-Fremont
- Saint Rose Hospital
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- El Camino Hospital
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Stanford Cancer Institute Palo Alto
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Denver Veterans Administration Medical Center
- University of Florida Health Science Center - Gainesville
- University of Florida Health Science Center - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Heartland Cancer Research NCORP
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Kewanee Hospital
- Mcdonough District Hospital
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Valley Radiation Oncology
- Perry Memorial Hospital
- Saint Margaret's Hospital
- Franciscan Saint Margaret Health-Hammond Campus
- Indiana University/Melvin and Bren Simon Cancer Center
- Franciscan Saint Anthony Health-Michigan City
- University of Maryland/Greenebaum Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Beaumont Hospital-Dearborn
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Allegiance Health
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Mercy Hospital-Joplin
- CHI Health Good Samaritan
- John F Kennedy Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers New Jersey Medical School
- Duke Women's Cancer Care Raleigh
- Rex Cancer Center
- University of Oklahoma Health Sciences Center
- Bryn Mawr Hospital
- Paoli Memorial Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Reading Hospital
- Lankenau Medical Center
- Main Line Health NCORP
- Audie L Murphy Veterans Affairs Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- University of Washington Medical Center
- Wheeling Hospital/Schiffler Cancer Center
- University of Wisconsin Hospital and Clinics
- Froedtert and the Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Phase I: MGd 3 mg/kg
Phase I: MGd 4 mg/kg
Phase I: MGd 5 mg/kg
Phase II: MGd 5 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40.Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.