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Talabostat in Treating Patients With Metastatic Kidney Cancer

This study has been withdrawn prior to enrollment.
(Terminated for safety reasons)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00489710
First received: June 20, 2007
Last updated: May 7, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 University of Nebraska:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: At progression or death from any cause ] [ Designated as safety issue: No ]
    Kaplan-Meier method

  • Objective response rate [ Time Frame: At 9 and 12 evaluable patients ] [ Designated as safety issue: No ]
    Evaluable patients are those that have completed 4 cycles of treatment.


Secondary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: At end of each course ] [ Designated as safety issue: Yes ]
  • Adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: At end of each course ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2006
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: Talabostat
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00489710     History of Changes
Other Study ID Numbers: 401-05, CDR0000549510
Study First Received: June 20, 2007
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014