Status:
UNKNOWN
Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
Hippocrate Research & Development
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Gastrointestinal stromal tumor (GIST) is a specific, immunohistochemically KIT+ mesenchymal neoplasm of the gastrointestinal tract. The identification of KIT+ tumor has become more important after int...
Eligibility Criteria
Inclusion
- GIST patient considered initially non-resectable as defined by one of the following:
- when the surgical team considers that the risk of incomplete resection (R1 or R2) of a GIST is higher than 20%
- when the resection of a GIST necessitates a highly morbid procedure
- when a GIST is attached to 3 or more major intra-abdominal structures or to a major intra-abdominal blood vessel
- 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
- 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:
- absolute neutrophil count \< 1.5 E+09/L
- platelet count \< 80000 E+09/L
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00290485
Start Date
August 1 2005
Last Update
April 7 2006
Active Locations (1)
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1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, h1t 2m4