Clinical trial NCT00500188 (phase 2, status: completed)
Conditions: gastrointestinal stromal tumors
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: imatinib mesylate (gleevec)
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent.

          2. Patients must have a histologically proven diagnosis of primary, locally advanced
             and/or metastatic GIST for which complete or partial resection is planned by a MDACC
             sarcoma surgeon.

          3. Patients must have immunohistochemical documentation of kit expression in the tumor
             using the DAKO A4502 or other acceptable antibody.

          4. Patients must have a least one lesion greater than 1 cm that can be accurately
             measured in one dimension by plain radiograph, CT or magnetic resonance imaging (MRI).

          5. Patients must have normal organ and marrow function (White blood count-WBC greater
             than or equal to 3,000/ul, Absolute neutrophil count (ANC) greater than or equal to
             1500/ul, platelets greater than or equal to 100,00/ul, total bilirubin less than or
             equal to 1.5 * Upper Limits of Normal (ULN), aspartate aminotransferase (AST or SGOT)
             or alanine aminotransferase (ALT or SGPT) less than or equal to 2.5 * ULN, serum
             creatinine less than or equal to 1.5 * ULN).

          6. Patients must have a serum glucose < 200 mg/dl prior to PET scan. Patients must be
             able to lie flat and still for the PET scan.

          7. Patients may not have any uncontrolled medical or psychiatric conditions that would
             make the patient unable to tolerate therapy. Patients with uncontrolled medical
             conditions or psychiatric conditions may have informed consent granted by a legal
             guardian or surrogate decision maker.

          8. Patients may not have any prior malignancy in the past 5 years other than non-melanoma
             skin cancer, cervical cancer in situ, or any other malignancy that is not currently
             clinically significant.

          9. Zubrod performance status of 0 - 3.

         10. May not have metastases outside of the peritoneal cavity.

         11. If patients have any signs or symptoms of metastases, the appropriate workup should
             occur prior to enrollment (eg, CT of the head for a patient with central nervous
             system (CNS) symptoms).

         12. Patients may not have had chemotherapy, radiotherapy, biological therapy or any
             investigational drugs 3 weeks prior to the study.

         13. Women should have a negative pregnancy test within 7 days of study opening.

         14. Patients must agree to use an effective contraceptive method.

        Exclusion Criteria:

          1. Prior treatment using Gleevec.

          2. Patients with Class III or Class IV New York Heart Association congestive heart
             failure.

          3. Pregnant or nursing women.

          4. Patients taking therapeutic doses of Coumadin for anticoagulation. Coumadin may be
             taken but dose should be less than or equal to 1 mg po per day. Patients MAY take a
             low molecular weight heparin.