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Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Imatinib mesylate
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring non-resectable tumor, high-risk tumor, metastasis, Response Evaluation Criteria in Solid Tumors (RECIST), Gleevec, Imatinib mesylate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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: 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.

Sites / Locations

  • Maisonneuve-Rosemont HospitalRecruiting

Outcomes

Primary Outcome Measures

Patient response rate according to RECIST criteria

Secondary Outcome Measures

Clinical response to treatment
Radiological response to treatment
Pathological response to treatment
Compare clinical with pathological response
Evaluate the impact of Gleevec on surgical morbidity
Evaluate disease-free survival
Evaluate overall survival
Evaluate whether the response rate can predict survival

Full Information

First Posted
February 9, 2006
Last Updated
April 6, 2006
Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Hippocrate Research & Development
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1. Study Identification

Unique Protocol Identification Number
NCT00290485
Brief Title
Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)
Official Title
A Phase II Study on Preoperative Administration of Gleevec in Patients With Initially Non-Resectable Gastrointestinal Stromal Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Hippocrate Research & Development

4. Oversight

5. Study Description

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 introduction of target treatment with KIT tyrosine kinase inhibitor Imatinib mesylate (Gleevec). Despite this progress, GIST patients presenting a tumor larger than 5 cm have a 10 year survival between 10% and 30%. Indeed, the risk of microscopic spreading of the tumor during surgery is very high since intra-abdominal organs are in close relation to each others. To improve survival, it seemed logical to use preoperative Gleevec to reduce tumor size and improve efficacy of the surgical procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
non-resectable tumor, high-risk tumor, metastasis, Response Evaluation Criteria in Solid Tumors (RECIST), Gleevec, Imatinib mesylate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate
Primary Outcome Measure Information:
Title
Patient response rate according to RECIST criteria
Secondary Outcome Measure Information:
Title
Clinical response to treatment
Title
Radiological response to treatment
Title
Pathological response to treatment
Title
Compare clinical with pathological response
Title
Evaluate the impact of Gleevec on surgical morbidity
Title
Evaluate disease-free survival
Title
Evaluate overall survival
Title
Evaluate whether the response rate can predict survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Dubé, MD
Phone
(514) 252-3822
Email
pierredube@videotron.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
h1t 2m4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
Phone
(514) 252-3822
Email
pierredube@videotron.qc.ca
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD

12. IPD Sharing Statement

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Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

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