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Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery Clinical research trials and Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery. Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery clinical trial. Human subjects often obtain the finest healthcare possible for their Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery  Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
For Condition: gastrointestinal stromal tumor
Status: No longer recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gastrointestinal stromal tumor that was completely removed during surgery.
Details: OBJECTIVES: - Determine survival of patients with completely resected high-risk primary gastrointestinal stromal tumor treated with adjuvant imatinib mesylate. - Determine the 2- and 5-year rates of recurrence in patients treated with this drug. - Determine the toxicity of this drug in these patients. OUTLINE: Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-risk primary gastrointestinal stromal tumor - High-risk is defined as any of the following: - Tumor at least 10 cm in greatest dimension - Presence of tumor rupture before or during surgery - Intraperitoneal hemorrhage - Multifocal intraperitoneal tumors - Complete gross tumor resection performed within the past 70 days - Includes R0 (negative microscopic margins) and R1 (positive microscopic margins) resection - Kit protein positive - No residual disease on CT scan or MRI of the abdomen or pelvis PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - No active infection requiring antibiotics within the past 14 days - No other prior malignancy within the past 5 years except: - Effectively treated basal cell or squamous cell skin cancer - Carcinoma in situ of the cervix effectively treated by surgery alone - Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone - At low risk for recurrence of curatively treated prior malignancies - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier-method contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No post-operative chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No post-operative radiotherapy Surgery: - See Disease Characteristics Other: - No prior imatinib mesylate - No post-operative investigational treatment - No concurrent full-dose warfarin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldDeMatteo, Study Chair, Memorial Sloan-Kettering Cancer Center
McKay-Dee Hospital Center
Ogden, Utah, 84403
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Watson Clinic
Lakeland, Florida, 33805
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9230
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Akron City Hospital
Akron, Ohio, 44309
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Greene Memorial Hospital
Xenia, Ohio, 45385
United States
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, 11203
United States
Orange Regional Medical Center - Horton Campus
Middletown, New York, 10940-4199
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
University Surgical Associates
Chattanooga, Tennessee, 37404
United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107
United States
Department of Surgery
Honolulu, Hawaii, 96813
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121-1598
United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
United States
St. John's Hospital
Springfield, Illinois, 62769
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Dixie Regional Medical Center
St. George, Utah, 84770
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Central Baptist Hospital
Lexington, Kentucky, 40503-9985
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Good Samaritan Hospital
Dayton, Ohio, 45406-1891
United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Miami Valley Hospital
Troy, Ohio, 45373
United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201
United States
Community Hospital of the Monterey Peninsula
Monterey, California, 93940
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States
Lakeland Regional Medical Center
Lakeland, Florida, 33804
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94122-2722
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460
United States
Creighton University School of Medicine
Omaha, Nebraska, 68131
United States
Ogden Regional Medical Center
Ogden, Utah, 84405
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
St. Agnes Healthcare
Baltimore, Maryland, 21229
United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404
United States
American Fork Hospital
American Fork, Utah, 84003
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
University of Florida - Gainesville
Gainesville, Florida, 32610-0277
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Additional Information:
Study ID Numbers: CDR0000068942; CWRU-020313,CTSU,ACOSOG-Z9000
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025246
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 Ohio Clinical Trials
Other Troy Clinical Trials
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
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