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Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery Clinical research trials and Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery. Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery clinical trial. Participants frequently get the best healthcare available for their Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery  Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery
Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery
For Condition: gastrointestinal stromal tumor
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI),National Cancer Institute of Canada,Cancer and Leukemia Group B,Southwest Oncology Group
Synopsis: RATIONALE: Imatinib mesylate (Gleevec; STI571) may interfere with the growth of tumor cells and may be an effective treatment for patients with primarygastrointestinal stromal tumor that has been completely removed by surgery. PURPOSE: Randomizedphase III trial to determine the effectiveness of imatinib mesylate (Gleevec; STI571) in treating patients who have primary gastrointestinal stromal tumor that has been completely removed by surgery.
Details: OBJECTIVES: - Compare the overall and recurrence-free survival of patients with resected primary gastrointestinal stromal tumor treated with adjuvant imatinib mesylate (Gleevec; STI571) vs placebo. - Determine the safety and efficacy of adjuvant imatinib mesylate in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover, multicenter study. Patients are stratified according to tumor size (3 cm but less than 6 cm vs 6 cm to less than 10 cm vs 10 cm or greater). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral imatinib mesylate (Gleevec; STI571) once daily. Treatment continues for 1 year in the absence of unacceptable toxicity. Patients who develop a recurrence during the year of initial treatment receive imatinib mesylate (Gleevec; STI571) at an increased dose. Patients who develop a recurrence after the year of initial treatment restart imatinib mesylate (Gleevec; STI571) and continue taking the drug for an additional year. - Arm II: Patients receive oral placebo once daily. Treatment continues for 1 year in the absence of unacceptable toxicity. Patients who develop a recurrence at any time discontinue placebo and crossover to arm I. Treatment on arm I continues for 1 year. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 380 patients will be accrued for this study within 3.8 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary gastrointestinal tumor (GIST) - Tumor size at least 3 cm in maximum dimension - No peritoneal or distant metastasis - Prior complete gross resection of a primary GIST within the past 14-70 days - R0 resection (negative microscopic margins) OR - R1 resection (positive microscopic margins) - Tumor must stain positive for Kit receptor tyrosine kinase by immunohistochemistry using the Dako anti-CD117 antibody - No objective evidence of residual disease on the postoperative CT scan or MRI of the abdomen or pelvis PATIENT CHARACTERISTICS: Age: - 18 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) (unless elevation is secondary to Gilbert's disease) - AST and 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 cardiac disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 3 months after study participation - No other 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 - Prior malignancies must be deemed at low risk for recurrence - No active infection requiring antibiotics within the past 14 days PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent anticancer biologic agents Chemotherapy: - No prior postoperative chemotherapy - No concurrent anticancer chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior postoperative radiotherapy Surgery: - See Disease Characteristics Other: - No prior postoperative investigational treatment - No prior imatinib mesylate (Gleevec; STI571) - No other concurrent anticancer agents - No other concurrent investigational drugs - No concurrent full-dose warfarin for therapeutic anticoagulation (concurrent mini-dose warfarin [1 mg orally per day] for prophylaxis of central venous catheter thrombosis allowed)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherRyan, Study Chair, University of Chicago Cancer Research Center
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-7375
United States
Recruiting John Niederhuber 608-265-5212
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center *Recruiting*
Savannah, Georgia, 31403-3089
United States
Recruiting Steven Brower 912-350-5900
Sinai Hospital of Baltimore *Recruiting*
Baltimore, Maryland, 21215
United States
Recruiting Mukund Didolkar 410-601-8317
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Shreyaskumar Patel 713-794-4632
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Abington Memorial Hospital *Recruiting*
Abington, Pennsylvania, 19001
United States
Recruiting Christopher Pezzi 215-346-4283
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
Baptist Hospital *Recruiting*
Nashville, Tennessee, 37236
United States
Recruiting Pat Whitworth 615-284-8229
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Christina Finlayson 303-315-8671
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Richard Barth 603-650-7903
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Mohammad Khan 715-387-5426
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Brett Sheppard 503-494-8372
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Jeffrey Milliken 714-456-3634
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital *Recruiting*
Allentown, Pennsylvania, 18105-1556
United States
Recruiting Gerald Sherwin 610-402-7884
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Bruce Averbook 216-778-4795
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
Mount Sinai Hospital - Toronto *Recruiting*
Toronto, Ontario, M5G 1X5
Canada
Recruiting Martin Blackstein 416-586-5371
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting R. Noyes 801-408-3555
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Charles Cox 813-972-8480
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting David Rothenberger 612-626-6122
Western Baptist Hospital *Recruiting*
Paducah, Kentucky, 42001
United States
Recruiting Harry Carloss 270-441-4343
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Queen's Cancer Institute at The Queen's Medical Center *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Byron Wong 808-942-9686
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting R. Noyes 801-408-3555
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Michael Simon 773-834-1634
Miami Valley Hospital *Recruiting*
Dayton, Ohio, 45409
United States
Recruiting Daniel McKellar 937-832-9310
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting Robert W. Marsh 352-392-0058
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Orange Regional Medical Center - Horton Campus *Recruiting*
Middletown, New York, 10940-4199
United States
Recruiting Howard Karpoff 845-692-3111
Spectrum Health Downtown Campus *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Leon Oostendorp 616-456-8613
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
St. Francis Medical Center *Recruiting*
Honolulu, Hawaii, 96817
United States
Recruiting Jan Wong 808-586-2920
Cottonwood Hospital Medical Center *Recruiting*
Murray, Utah, 84107
United States
Recruiting R. Noyes 801-408-3555
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting David Winchester 847-570-2807
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Murray Brennan 212-639-8691
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Mark Krasna 410-328-6366
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Sheryl Gabram 708-327-2695
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Cancer Care and Research Pavilion at St. Joseph's/Candler *Recruiting*
Savannah, Georgia, 31405-6015
United States
Recruiting Ramesh Patwardhan 912-692-6360
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Steven Grunberg 802-847-8400
State University of New York Health Science Center at Brooklyn College of Medicine *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting William Solomon 718-270-2785
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110-1093
United States
Recruiting Timothy Eberlein 314-454-1898
Central Baptist Hospital *Recruiting*
Lexington, Kentucky, 40503-9985
United States
Recruiting Peter Tate 606-277-5711
Keesler Medical Center - Keesler Air Force Base *Recruiting*
Keesler AFB, Mississippi, 39534-2576
United States
Recruiting David Rose 228-377-6272
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Karen Albritton 801-585-0255
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Richard Swanson 617-732-8818
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Saint Thomas Hospital *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Pat Whitworth 615-284-8229
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Robert Packer Hospital *Recruiting*
Sayre, Pennsylvania, 18840-1698
United States
Recruiting Thomas VanderMeer 570-882-2382
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Edward Levine 336-716-4276
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Douglas Tyler 919-684-6858
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting R. Noyes 801-408-3555
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Alonzo Walker 414-454-5737
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110-0250
United States
Recruiting Frank Johnson 314-577-8312
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0527
United States
Recruiting Celia Chao 409-772-0698
Lakeland Regional Cancer Center *Recruiting*
Lakeland, Florida, 33804-1057
United States
Recruiting Douglas Reintgen 863-603-6565
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
St. Agnes Cancer Center *Recruiting*
Baltimore, Maryland, 21229
United States
Recruiting Armando Sardi 410-368-2702
Presbyterian Hospital *Recruiting*
Charlotte, North Carolina, 28233-3549
United States
Recruiting Peter Turk 704-377-3900
Danville Radiation Therapy Center *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
Sarah Cannon Cancer Center at Parkridge Medical Center *Recruiting*
Chattanooga, Tennessee, 37404-3285
United States
Recruiting John Gwin 423-267-0466
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Frederick Greene 704-355-3176
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting R. Noyes 801-408-3555
University Surgical Associates *Recruiting*
Chattanooga, Tennessee, 37404
United States
Recruiting John Gwin 423-267-0466
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Ronald Weigel 215-955-0526
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Marc Miller 573-882-8454
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Richard Bold 916-734-7269
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting Gary Mann 206-221-7163
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting William Burak 614-293-8550
Additional Information:
Study ID Numbers: CDR0000069452; SWOG-ACOSOG-Z9001,ACOSOG-Z9001,CAN-NCIC-SRC1,CALGB-ACOSOG-Z9001
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041197
Other Gastrointestinal Stromal Tumor Studies:
1. Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
2. Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
3. Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery
4. Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
5. Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors
Related Studies:
Other gastrointestinal stromal tumor Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery
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