Kidney Cancer Clinical Trial
Official title:
A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well talabostat works in treating patients with metastatic kidney cancer.
OBJECTIVES: Primary - Determine the response rate in patients with metastatic renal cell carcinoma treated with talabostat mesylate. - Determine the progression-free survival of patients treated with this drug. Secondary - Determine the toxicity of this drug in these patients. - Correlate changes in specific cytokine levels and peripheral blood flow cytometry with progression-free survival. OUTLINE: This is a nonrandomized study. Patients receive oral talabostat mesylate once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood samples are obtained from patients at baseline and after each course for biomarker correlative studies. Samples are analyzed for serum cytokines and chemokines and for T-cell subsets and natural killer (NK) cells by flow cytometry. Peripheral blood lymphocytes are obtained at baseline and after course 1 for future assessment by gene microarray analysis. ;
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