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Talabostat in Treating Patients With Metastatic Kidney Cancer
This study has been terminated.
( Terminated for safety reasons )
First Received: June 20, 2007   Last Updated: January 22, 2008   History of Changes
Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00489710
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate
  • Progression-free survival

Secondary Outcome Measures:
  • Dose-limiting toxicity
  • Adverse events as assessed by NCI CTCAE v3.0

Estimated Enrollment: 30
Study Start Date: December 2006
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 NK cells by flow cytometry.

Peripheral blood lymphocytes are obtained at baseline and after course 1 for future assessment by gene microarray analysis.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologic diagnosis of renal cell carcinoma

    • Clinical confirmation of metastatic disease required
  • 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:

        • Small lesions (longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan)
        • Bone lesions
        • Leptomeningeal disease
        • Ascites
        • Pleural or pericardial effusion
        • Lymphangitis cutis or pulmonis
        • Abdominal masses that are not confirmed and followed by imaging techniques
        • Cystic lesions
  • Progressed after ≥ 1 multikinase inhibitor regimen (i.e., sorafenib tosylate or sunitinib malate)
  • No history of CNS or brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.5 g/dL (no packed red blood cell transfusions within the past 4 weeks) (epoetin alfa support allowed)
  • Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (unless due to Gilbert's syndrome)
  • AST and ALT ≤ 3 times ULN
  • Creatinine < 2.0 mg/dL
  • No active serious infections
  • No other malignancy within the past 5 years except basal cell or nonmetastatic squamous cell skin cancer or carcinoma in situ of the cervix
  • No comorbidity or concurrent condition that would interfere with protocol assessments or procedures
  • No ongoing coagulopathy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior systemic therapy and recovered
  • Prior radiotherapy allowed as long as the lesion treated is not used to assess response
  • No prior radiotherapy to > 50% of the bone marrow
  • No prior radiotherapy to index lesions unless there is clearly progressive disease within the irradiated area OR measurable disease outside the irradiated area
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489710

Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Ralph Hauke, MD University of Nebraska
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009