Talabostat in Treating Patients With Metastatic Kidney Cancer
|ClinicalTrials.gov Identifier: NCT00489710|
Recruitment Status : Withdrawn (Terminated for safety reasons)
First Posted : June 21, 2007
Last Update Posted : May 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma|
|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|
- Progression-free survival [ Time Frame: At progression or death from any cause ]Kaplan-Meier method
- Objective response rate [ Time Frame: At 9 and 12 evaluable patients ]Evaluable patients are those that have completed 4 cycles of treatment.
- Dose-limiting toxicity [ Time Frame: At end of each course ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: At end of each course ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489710
|Principal Investigator:||Ralph Hauke, MD||University of Nebraska|