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A Phase II Study of Adjuvant STI571 (Gleevec TM) Therapy in Patients Following Completely Resected High-risk Primary GastroIntestinal Stromal Tumor (GIST)

Phase 2
16 Years
Not Enrolling
Gastrointestinal Stromal Tumor

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Trial Information

A Phase II Study of Adjuvant STI571 (Gleevec TM) Therapy in Patients Following Completely Resected High-risk Primary GastroIntestinal Stromal Tumor (GIST)


I. To ascertain whether patients with completely resected high-risk primary GIST who undergo
adjuvant treatment with STI571 have prolonged survival compared to historical controls.


I. To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant
STI571 following complete resection of high-risk primary GIST.

II. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and at the
time of recurrence), blood specimens (before therapy with STI571), and serum specimens
(before therapy with STI571, after completing therapy with STI571, and at the time of
recurrence) for scientific correlative analyses.

III. To assess the toxicity of oral STI571 therapy when used in the adjuvant setting.


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.

After completion of study treatment, patients are followed periodically for up to 10 years.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with imatinib mesylate have prolonged survival compared to historical controls

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Ronald DeMatteo

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Surgeons


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors



American College of Surgeons Oncology Group Durham, North Carolina  27705