Conditions: Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Efficacy of Bay 43-9006 with or without low dose interferon by evaluating response rate in MRCC.

II. Toxicities of Bay 43-9006 with or without low dose interferon in MRCC.

SECONDARY OBJECTIVES:

I. Progression free survival. II. Duration of response. III. Overall Survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral sorafenib twice daily on days 1-28.

Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28.

In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.

Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.

After completion of study treatment, patients are followed every 3 months.

Arms:
arm 1: Arm I: Oral Sorafenib 400 mg twice daily on days 1-28. arm 2: Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.

Interventions: intervention 1: Sorafenib Tosylate intervention 2: Recombinant Interferon Alfa-2b intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given orally 400 mg orally (PO) every 12 hours intervention 2: Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10\^6 international units twice daily intervention 3: Correlative studies

Protocol document: