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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058097 |
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: tipifarnib Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of R115777 For The Treatment Of Adults With Newly Diagnosed Glioblastoma Multiforme |
Study Start Date: | August 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A minimum of 54 patients will be accrued for this study within 11-14 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial grade IV astrocytoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior biologic therapy for brain tumor, including any of the following:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 10 days since prior hepatic metabolic enzyme-inducing anticonvulsant drugs, including the following:
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1030 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abramson Cancer Center at University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Robert A. Lustig, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000285732, NABTT-2200, JHOC-NABTT-2200 |
Study First Received: | April 7, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00058097 |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Nervous System Neoplasms Tipifarnib Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |