Talabostat in Treating Patients With Metastatic Kidney Cancer
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.
Drug: talabostat mesylate
Procedure: diagnostic procedure
Procedure: enzyme inhibitor therapy
Procedure: flow cytometry
Procedure: laboratory biomarker analysis
Procedure: non-specific immune-modulator therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma|
- Progression-free survival [ Time Frame: At progression or death from any cause ] [ Designated as safety issue: No ]Kaplan-Meier method
- Objective response rate [ Time Frame: At 9 and 12 evaluable patients ] [ Designated as safety issue: No ]Evaluable patients are those that have completed 4 cycles of treatment.
- Dose-limiting toxicity [ Time Frame: At end of each course ] [ Designated as safety issue: Yes ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: At end of each course ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Study Completion Date:||May 2007|
Talabostat 600 mcg PO QD x 14 days (21 day cycle); 2 cycles
|Drug: talabostat mesylate Procedure: diagnostic procedure Procedure: enzyme inhibitor therapy Procedure: flow cytometry Procedure: laboratory biomarker analysis Procedure: non-specific immune-modulator therapy|
- 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.
- 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 NK cells by flow cytometry. Peripheral blood lymphocytes are obtained at baseline and after course 1 for future assessment by gene microarray analysis.
|Principal Investigator:||Ralph Hauke, MD||University of Nebraska|