Stage IV Renal Cell Cancer Clinical Trial
Official title:
A Phase II Trial of G3139 (Genasense) Anti-Bcl-2 Antisense Oligonucleotide Plus Alpha-Interferon in Metastatic Renal Cancer
Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug.
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of metastatic renal cancer to the combination of
G3139 plus α-Interferon (α-IFN).
SECONDARY OBJECTIVES:
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
schedule.
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
CR.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 20-24
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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