RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
OBJECTIVES: I. Evaluate the efficacy of carmustine, cisplatin, and etoposide administered prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme. II. Assess the toxicities of this treatment regimen in this patient population. III. Assess fatigue, depression, and excessive daytime somnolence in terms of incidence, duration, and relation to age, tumor type, tumor site, cancer therapy, and symptoms in this patient population. IV. Evaluate the quality of life of these patients. OUTLINE: Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses. Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
overall survival
Time frame: Up to 10 years
quality of life
Time frame: Up to 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
...and 9 more locations