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Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Clinical research trials and Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors. Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors clinical trial. Test subjects typically obtain the finest healthcare available for their Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors  Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors
Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors
For Condition: gastrointestinal stromal tumor
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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-intraabdominal leiomyosarcomas PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - WBC 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkZalupski, Study Chair, University of Michigan Comprehensive Cancer Center
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Oregon Cancer Institute
Portland, Oregon, 97201-3098
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
Additional Information:
Study ID Numbers: CDR0000067710; SWOG-S9926
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005597
Other Gastrointestinal Stromal Tumor Studies:
1. Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors
2. Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
3. Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
4. Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
5. Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
Related Studies:
Other gastrointestinal stromal tumor Clinical Trials
Other Kansas Clinical Trials
Other Kansas City Clinical Trials
Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors
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