Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

Completed · Phase 2

Conditions studied: Gastrointestinal Stromal Tumor (GIST)

In brief

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.

Key facts

Study ID

NCT00867113

Run by

Novartis Pharmaceuticals

People needed

91

Starts

2009-07-22

Expected to finish

2016-12-20

Last updated by the study team

2018-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older.
• Patient must have had a histological diagnosis of primary GIST.
• The tumor must expressed KIT (CD117) protein by immunohistochemistry performed by central pathology.
• 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
• 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.
• 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.
• Performance status 0 or 1 (ECOG)
• 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
• 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.
• 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.
• Written, voluntary informed consent.

You may not qualify if…

• Patient has metastatic GIST to the peritoneum, liver, lymph node, or other sites or recurrent GIST.
• Prior treatment for GIST with the exception of prior treatment with imatinib adjuvant lasting ≤ 8 weeks following gross surgical resection.
• Patient has received any other investigational agents within 28 days of first day of study drug dosing.
• 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)
• 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).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin).
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Where it is running

• University of California San Diego - Moores Cancer Center Moores UCSD Cancer Center (31) — La Jolla, California, United States
• University of Colorado University of Colorado — Aurora, Colorado, United States
• Washington Hospital Center Department of Medical Oncology — Washington D.C., District of Columbia, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Longstreet Cancer Center — Gainesville, Georgia, United States
• Kootenai Medical Center Kootenai Cancer Cancer — Coeur d'Alene, Idaho, United States
• North Shore University Health System — Evanston, Illinois, United States
• Dana Farber Cancer Institute Dana-Farber — Boston, Massachusetts, United States
• Karmanos Cancer Institute Karmonos Cancer Instit. (40) — Detroit, Michigan, United States
• Washington University School of Medicine Center for Advanced Medicine — St Louis, Missouri, United States
• Southern Nevada Cancer Research Foundation S. Nevada Cancer Res (2) — Las Vegas, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (7) — New York, New York, United States
• Duke University Medical Center Duke University Med Ctr (8) — Durham, North Carolina, United States
• Oregon Health & Science University OHS University — Portland, Oregon, United States
• Penn State University / Milton S. Hershey Medical Center Penn Stat University — Hershey, Pennsylvania, United States
• Roger Williams Medical Center Medical Center — Providence, Rhode Island, United States
• Kingport Hematology Oncology — Kingsport, Tennessee, United States
• MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (4) — Houston, Texas, United States
• South Texas Oncology and Hematology, PA South Texas Onc/Hem — San Antonio, Texas, United States
• Virginia Oncology Associates Viriginia Oncology Assoc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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