Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
Condition: Gastrointestinal Stromal Tumor (GIST)
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: imatinib mesylate
Intervention description: imatinib mesylate was supplied in 100 and 400 mg tablets
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Imatinib; Protein Kinase Inhibitors; Gastrointestinal Stromal Tumors; Digestive System Diseases; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Adjuvant; PERSIST; PERSIS-5

Summary:

      This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The
      purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in
      patients at significant risk for recurrence following complete resection of primary GIST.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 18 years of age or older.

          2. Patient must have had a histological diagnosis of primary GIST.

          3. The tumor must expressed KIT (CD117) protein by immunohistochemistry performed by
             central pathology.

          4. Patient must have been at significant risk of tumor recurrence as defined by either:

               -  Primary GIST (any site): ≥ 2 cm and a mitotic rate of ≥ 5/50 HPF's

               -  Non-gastric primary GIST: ≥ 5cm

          5. Patient must have undergone complete gross resection of a primary GIST within 12 weeks
             prior to first dose of imatinib study drug. The inclusion of R1 resections will be
             reviewed on a case by case basis by the Study Management Committee.

          6. Patient must had no evidence of metastatic GIST on either 1) a post-operative CT of
             the abdomen and pelvis with intravenous and oral contrast or 2) MRI of the abdomen and
             pelvis with intravenous contrast. CT or MRI must have been performed within 8 weeks
             prior to first dose of imatinib study drug.

          7. Performance status 0 or 1 (ECOG)

          8. Patient must had the following post-operative laboratory values confirmed within 14
             days prior to first dose of imatinib study drug:

               -  total bilirubin < 1.5 x ULN NOTE: Patients with elevated bilirubin secondary to
                  Gilbert's disease are eligible to participate in the study.

               -  ALT and AST < 2.5 x ULN

               -  creatinine < 1.5 x ULN

               -  ANC > 1.5 x 109/L

               -  platelets > 100 x 109/L

          9. If patient is a cancer survivor, ALL of the following criteria apply:

               -  Patient had undergone potentially curative therapy for all prior malignancies.

               -  No evidence of any prior malignancies for at least 3 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.

         10. Female patients of childbearing potential must have had negative pregnancy test within
             7 days before initiation of study drug dosing. Postmenopausal women must have been
             amenorrheic for at least 12 months to be considered of non-childbearing potential.
             Female patients of reproductive potential must have jagreed to employ an effective
             barrier method of birth control throughout the study and for up to 7 days following
             discontinuation of study drug.

         11. Written, voluntary informed consent.

        Exclusion Criteria:

          1. Patient has metastatic GIST to the peritoneum, liver, lymph node, or other sites or
             recurrent GIST.

          2. Prior treatment for GIST with the exception of prior treatment with imatinib adjuvant
             lasting ≤ 8 weeks following gross surgical resection.

          3. Patient has received any other investigational agents within 28 days of first day of
             study drug dosing.

          4. Patient with Grade III/IV cardiac problems as defined by the New York Heart
             Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6
             months of study)

          5. Patients with severe and/or uncontrolled concurrent medical disease that in the
             opinion of the investigator could cause unacceptable safety risk or compromise
             compliance with the protocol (i.e., uncontrolled diabetes, chronic renal disease,
             chronic liver disease, or active uncontrolled infection).

          6. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

          7. Patient receiving concurrent treatment with warfarin (acceptable alternative:
             low-molecular weight heparin).

          8. Patient with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent.

             -