S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
- Registration Number
- NCT00005597
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors.
- Detailed Description
OBJECTIVES:
* Determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide.
* Determine the qualitative or quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response (CR) receive 2 additional courses after a confirmed CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 13-27 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Temozolomide temozolomide 200 mg/m\^2/day, PO, on Days 1-5 of each 28 day cycle.
- Primary Outcome Measures
Name Time Method Assess response (confirmed & unconfirmed, complete & partial response) 3 years
- Secondary Outcome Measures
Name Time Method Toxicities 3 years
Trial Locations
- Locations (106)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Danville Radiation Therapy Center
🇺🇸Memphis, Tennessee, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Institute
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States