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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00489710 |
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 | Intervention | Phase |
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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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologic diagnosis of renal cell carcinoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or
10 mm by spiral CT scan
The following are considered nonmeasurable disease:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000549510, UNMC-40105 |
Study First Received: | June 20, 2007 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00489710 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Enzyme Inhibitors Urologic Neoplasms Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |