Clinical trial NCT00025246 (phase 2, status: completed)
Conditions: gastrointestinal stromal tumor
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: imatinib mesylate
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:

          -  Patient must have an ECOG/Zubrod performance status of ≤ 2

          -  Patient must have a diagnosis of high-risk primary GIST; NOTE: High risk is defined as
             tumor size ≥ 10 cm in maximum dimension, or the presence of tumor rupture before or
             during surgery, intraperitoneal hemorrhage or multifocal (< 5) intraperitoneal tumors

          -  Patient must have undergone complete gross resection (includes R0 [negative
             microscopic margins] and R1 [positive microscopic margins] resections) of a primary
             GIST within 70 days prior to registration

          -  Patient must have a histologic diagnosis of GIST that is confirmed by central
             pathology review

          -  Patient's tumor must stain positive for the Kit receptor tyrosine kinase on
             immunohistochemistry as determined by the central pathologist using the Dako (Dako
             Corp., Carpinteria, CA) anti-CD 117 antibody

          -  Patient must have a chest x-ray completed within 28 days prior to registration

          -  Patient must have a post-operative CT scan with IV and PO contrast or MRI with
             contrast (if allergic to CT contrast) of abdomen and pelvis within 28 days prior to
             registration

          -  Creatinine ≤ 1.5 times the institution ULN

          -  WBC ≥ 2,000/mm^3

          -  Platelet ≥ 100,000/mm^3

          -  Total bilirubin ≤ 1.5 times the institution ULN

          -  AST and ALT ≤ 2.5 times the institution ULN

          -  Female of childbearing potential must have negative serum pregnancy test

          -  Patient or the patient's legally acceptable representative must provide a signed and
             dated written informed consent prior to registration and any study related procedures

          -  If patient is a cancer survivor, each of the following criteria must apply:

               -  Patient has undergone potentially curative therapy for all prior malignancies,

               -  No evidence of any prior malignancies for at least 5 years with no evidence of
                  recurrence (except for effectively treated basal cell or squamous carcinoma of
                  the skin, carcinoma in-situ of the cervix that has been effectively treated by
                  surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral
                  breast treated by surgery alone)

               -  Patient is deemed by their treating physician to be at low risk for recurrence
                  from prior malignancies

        Exclusion Criteria:

          -  Patient has received post-operative chemotherapy

          -  Patient has received post-operative radiation therapy

          -  Patient has received post-operative investigational treatment

          -  Patient has received prior therapy with STI571

          -  Patient has had an active infection requiring antibiotics within 14 days prior to
             registration

          -  Patient has objective evidence of residual disease on the post-operative CT scan or
             MRI of the abdomen or pelvis

          -  Patient, if female and breastfeeding; NOTE: It is not known whether STI571 or its
             metabolites are excreted in human milk; however, in lactating female rats administered
             100 mg/kg, a dose approximately equal to the maximum clinical dose of 800 mg/day based
             on body surface area, STI571 and/or its metabolites were extensively excreted in milk;
             it is estimated that approximately 1.5% of a maternal dose is excreted into milk,
             which is equivalent to a dose to the infant of 30% the maternal dose per unit body
             weight; because many drugs are excreted in human milk and because of the potential for
             serious adverse reactions in nursing infants, women should be advised against
             breastfeeding while taking STI571

          -  Patient has New York Heart Association class 3 or 4 cardiac disease

          -  Patient is taking full dose warfarin; NOTE: The use of mini-dose warfarin (1 mg orally
             per day) for prevention of central line-associated deep venous thrombosis is permitted