S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
Gastrointestinal Stromal Tumor
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring gastrointestinal stromal tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST) Primary (gastrointestinal or intra-abdominal origin) tumor At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC (white blood count) at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No medical or psychological conditions that would preclude study participation No major infection requiring systemic antibiotics No uncontrolled bacterial, viral, or fungal infection No other prior malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer in complete remission Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior biologic therapy Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed Chemotherapy: No prior chemotherapy for GIST At least 30 days since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for GIST No concurrent radiotherapy for GIST Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Other: At least 30 days since prior investigational drugs
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- City of Hope Comprehensive Cancer Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Cancer Center
- UCSF Comprehensive Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- MBCCOP - Hawaii
- Tripler Army Medical Center
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Henry Ford Hospital
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Hospital - Southfield
- CCOP - Duluth
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Veterans Affairs Medical Center - Albany
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Barrett Cancer Center
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- CCOP - Toledo Community Hospital
- University of Oklahoma Health Sciences Center
- Veterans Affairs Medical Center - Oklahoma City
- Oregon Cancer Institute
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee Cancer Institute
- Danville Radiation Therapy Center
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Veterans Affairs Medical Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Veterans Affairs Medical Center - Houston
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- Fletcher Allen Health Care - University Health Center Campus
- MBCCOP - Massey Cancer Center
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
- Madigan Army Medical Center
Arms of the Study
Arm 1
Experimental
Temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.