Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003996 |
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.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: cisplatin Drug: etoposide Procedure: chemotherapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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) |
Estimated Enrollment: | 84 |
Study Start Date: | May 1999 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Louisiana | |
CCOP - Ochsner | |
New Orleans, Louisiana, United States, 70121 | |
United States, Minnesota | |
CCOP - Duluth | |
Duluth, Minnesota, United States, 55805 | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
CentraCare Clinic | |
Saint Cloud, Minnesota, United States, 56303 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68131 | |
United States, North Dakota | |
Altru Health Systems | |
Grand Forks, North Dakota, United States, 58201 | |
Quain & Ramstad Clinic, P.C. | |
Bismarck, North Dakota, United States, 58501 | |
United States, Ohio | |
CCOP - Toledo Community Hospital Oncology Program | |
Toledo, Ohio, United States, 43623-3456 | |
United States, Pennsylvania | |
CCOP - Geisinger Clinical and Medical Center | |
Danville, Pennsylvania, United States, 17822-2001 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57105-1080 | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 |
Study Chair: | Timothy J. Moynihan, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067206, NCCTG-987252 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003996 |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Carmustine Central Nervous System Neoplasms Etoposide phosphate Neuroectodermal Tumors Cisplatin Glioblastoma multiforme |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Etoposide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Pharmacologic Actions Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Alkylating Agents |