Talabostat in Treating Patients With Metastatic Kidney Cancer
This study has been withdrawn prior to enrollment.
(Terminated for safety reasons)
Sponsor:
University of Nebraska
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
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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 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Immunologic Factors Enzyme Inhibitors Physiological Effects of Drugs Pharmacologic Actions Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013