Gastrointestinal Stromal Tumor Clinical Trial
Official title:
A Phase IIA Study to Determine the Safety and Efficacy of A NCI-Supplied Agent: G3139 (NSC 683428, IND 58842) and Imatinib Mesylate in Patients With Refractory or Relapsed Gastrointestinal Stromal Tumor
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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