Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Status: | Completed |
---|---|
Conditions: | Brain Cancer, Brain Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 1999 |
End Date: | May 2008 |
A Phase II Trial of Pre-irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)
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.
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.
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.
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme
No oligodendrogliomas or oligoastrocytomas
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 130,000/mm3
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater
than 2 times ULN Renal: Creatinine no greater than 0.5 mg/dL above ULN Other: No
uncontrolled infection No other major medical conditions No other concurrent malignancy
except superficial skin cancers Must be able to read English (quality of life assessment
only) No other problem that may preclude quality of life assessment Not pregnant or
nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: No prior
radiotherapy Surgery: Not specified
We found this trial at
19
sites
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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