Spots Global Cancer Trial Database for Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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