A Phase II Trial of G3139 (Genasense) Anti-Bcl-2 Antisense Oligonucleotide Plus Alpha-Interferon in Metastatic Renal Cancer
I. To estimate the objective response rate of metastatic renal cancer to the combination of
G3139 plus α-Interferon (α-IFN).
I. To further assess the clinical toxicity of this combination. II. To evaluate the impact
of G3139 plus α-IFN on molecular targets involved in the regulation of apoptosis in tumor
cells and lymphocytes.
III. To evaluate the pharmacokinetics of G3139 when given with α-IFN at this dose and
IV. To evaluate the potential toxicity of this combination on cells of the immune system.
OUTLINE: This is a multicenter study.
Patients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously
on days 4, 6, 8, 10, and 12 of course 1 and on days 1, 3, 5, 8, 10, and 12 of all subsequent
courses. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity. Patients achieving a complete remission (CR) receive an additional 2 courses past
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 20-24
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST)
Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
Start of the treatment until disease progression/recurrence, assessed up to 5 years
Beckman Research Institute
United States: Food and Drug Administration
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