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.

Condition	Treatment or Intervention	Phase
gastrointestinal stromal tumor	Drug: imatinib mesylate  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study 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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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

Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36640-0460,  United States
Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States
California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      Community Hospital of the Monterey Peninsula, Monterey,  California,  93940,  United States
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94122-2722,  United States
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States
      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121-1598,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
      Lakeland Regional Medical Center, Lakeland,  Florida,  33804,  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
      Watson Clinic, Lakeland,  Florida,  33805,  United States
Hawaii
      Department of Surgery, Honolulu,  Hawaii,  96813,  United States
Illinois
      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201,  United States
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62794-9230,  United States
      St. John's Hospital, Springfield,  Illinois,  62769,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Indiana
      St. Francis Hospital and Health Centers, Beech Grove,  Indiana,  46107,  United States
Kentucky
      Central Baptist Hospital, Lexington,  Kentucky,  40503-9985,  United States
Maryland
      Sinai Hospital of Baltimore, Baltimore,  Maryland,  21215,  United States
      St. Agnes Healthcare, Baltimore,  Maryland,  21229,  United States
Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States
Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States
Nebraska
      Creighton University School of Medicine, Omaha,  Nebraska,  68131,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States
New York
      James P. Wilmot Cancer Center, Rochester,  New York,  14642,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Orange Regional Medical Center - Horton Campus, Middletown,  New York,  10940-4199,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York Health Science Center at Brooklyn College of Medicine, Brooklyn,  New York,  11203,  United States
North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44309,  United States
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
      Good Samaritan Hospital, Dayton,  Ohio,  45406-1891,  United States
      Greene Memorial Hospital, Xenia,  Ohio,  45385,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
      Miami Valley Hospital, Troy,  Ohio,  45373,  United States
Oregon
      Oregon Cancer Institute, Portland,  Oregon,  97239,  United States
Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
Tennessee
      Associates in Oncology and Hematology, Chattanooga,  Tennessee,  37404,  United States
      Parkridge Medical Center, Chattanooga,  Tennessee,  37404,  United States
      University Surgical Associates, Chattanooga,  Tennessee,  37404,  United States
Texas
      Presbyterian Hospital of Dallas, Dallas,  Texas,  75231,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Utah
      American Fork Hospital, American Fork,  Utah,  84003,  United States
      Cottonwood Hospital Medical Center, Murray,  Utah,  84107,  United States
      Dixie Regional Medical Center, Saint George,  Utah,  84770,  United States
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States
      Latter Day Saints Hospital, Salt Lake City,  Utah,  84143,  United States
      McKay-Dee Hospital Center, Ogden,  Utah,  84403,  United States
      Ogden Regional Medical Center, Ogden,  Utah,  84405,  United States
      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States
Washington
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States
Wisconsin
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States

Study chairs or principal investigators

Ronald DeMatteo, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000068942; ACOSOG-Z9000; CTSU; CWRU-020313
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025246
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08