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Spots Global Cancer Trial Database for Talabostat in Treating Patients With Metastatic Kidney Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Talabostat in Treating Patients With Metastatic Kidney Cancer

Official Title: A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma

Study ID: NCT00489710

Conditions

Kidney Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Ralph Hauke, MD

Affiliation: University of Nebraska

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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