Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Oblimersen may help imatinib mesylate kill more tumor cells by making tumor cells more sensitive to the drug. This phase II trial is studying how well giving imatinib mesylate together with oblimersen works in treating patients with advanced gastrointestinal stromal tumor that cannot be removed by surgery.
PRIMARY OBJECTIVES: I. To determine the efficacy of G3139 (bcl-2 antisense oligonucleotide) plus imatinib mesylate in GIST patients with limited or generalized progression after therapy with imatinib. II. To assess the safety of G3139 plus imatinib mesylate in GIST patients with limited or generalized progression after therapy with imatinib. III. To determine whether expression of BCL-2 correlates with survival, time to progression or response rate in patients with GIST treated with G3139 plus imatinib. OUTLINE: This is a multicenter study. Patients are stratified according to extent of disease progression (limited vs generalized). Patients receive oblimersen IV continuously on days 1-14. Patients also receive oral imatinib mesylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 96 patients (48 per stratum) will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
M D Anderson Cancer Center
Houston, Texas, United States
Response defined using the Choi criteria
The design method of Thall, Simon and Estey will be used.
Time frame: 2 months
Toxicity defined as any of the following events: regimen-related death, transaminitis, infection, or leukopenia grade 3 or higher using NCI CTCAE version 3.0
The design of Thall, Simon and Estey will be used.
Time frame: 2 months
Disease-free survival
Regression analyses will be performed to assess the ability of patient prognostic factors to predict these time-to-event outcomes (survival analyses), as well as the probabilities of response and toxicity (logistic or extended logistic regression analyses).
Time frame: Up to 4 years
Overall survival
Regression analyses will be performed to assess the ability of patient prognostic factors to predict these time-to-event outcomes (survival analyses), as well as the probabilities of response and toxicity (logistic or extended logistic regression analyses).
Time frame: Up to 4 years
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