Talabostat in Treating Patients With Metastatic Kidney Cancer

Phase 2

Withdrawn

• Conditions: Kidney Cancer
• Interventions: Drug: talabostat mesylate; Biological: enzyme inhibitor therapy; Diagnostic Test: flow cytometry; Diagnostic Test: laboratory biomarker analysis; Biological: non-specific immune-modulator therapy

• Registration Number: NCT00489710
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-05-30
• Study Completion: 2007-05-30
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Talabostat	enzyme inhibitor therapy	Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
Talabostat	non-specific immune-modulator therapy	Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
Talabostat	flow cytometry	Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
Talabostat	laboratory biomarker analysis	Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
Talabostat	talabostat mesylate	Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles

Primary Outcome Measures

Name	Time	Method
Objective response rate	After 9 and 12 evaluable patients (126 to 168 days of total treatment). Each course is 14 days and repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Evaluable patients are those that have completed 4 cycles of treatment.

Secondary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Any grade 3-4 non-haematological or grade 4 haematological toxicity at least possibly related to treatment
Adverse events	From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Adverse events as assessed by NCI CTCAE v3.0