Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maisonneuve-Rosemont Hospital
• Collaborator: Hippocrate Research & Development
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• GIST patient considered initially non-resectable as defined by one of the following:

1. when the surgical team considers that the risk of incomplete resection (R1 or R2) of a GIST is higher than 20%

2. when the resection of a GIST necessitates a highly morbid procedure

3. when a GIST is attached to 3 or more major intra-abdominal structures or to a major intra-abdominal blood vessel

4. when GIST is considered at very high risk of recurrence. This is the case when it is a recurrence or when the tumor is in very close contact with a structure that cannot be resected by surgery or when the patient has metastasis.

• Outpatient is 18 years old or more

• ECOG performance status 0, 1 or 2

• Immunohistochemical confirmation of KIT overexpression must exist at the study entry

• Measurable disease on CT-Scan or MRI (ultrasound and/or operative finding are not acceptable) and response to RECIST criteria

• Have a life expectancy of at least 6 months

• Be willing and able to comply with the protocol (and surgery if required) for the duration of the study

• Give written informed consent prior to study-specific screening procedure, with the understanding that the patient has the right to withdraw from the study at any time without prejudice

Exclusion Criteria:

• received Imatinib in the past

• received a full course of radiotherapy within 3 months of inclusion in the study. A short course of radiotherapy to control bleeding is allowed.

• received systemic chemotherapy within 4 weeks of inclusion in the study

• received steroids for less than 4 weeks of inclusion in the study

• pregnant or lactating women

• women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.

• sexually active males or females (of childbearing potential) unwilling to practice contraception during the study

• history of other malignancy within the past 5 years, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix

• clinical or other evidence of CNS metastases

• myocardial infarction within the last 3 months

• any medical condition that contraindicates potential surgery

• lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication

• any serious uncontrolled concomitant disease

• any of the following laboratory values:

1. absolute neutrophil count < 1.5 E+09/L

2. platelet count < 80000 E+09/L

3. AST or ALT higher than 2 X normal

• major surgery within 4 weeks prior to start of study treatment, or lack of complete recovery from effects of major surgery

• patients with known or suspected hypersensitivity to one of the Gleevec components.