Talabostat in Treating Patients With Metastatic Kidney Cancer

University of Nebraska

Status and phase

Withdrawn

Phase 2

Conditions

Kidney Cancer

Treatments

Diagnostic Test: flow cytometry

Biological: enzyme inhibitor therapy

Diagnostic Test: laboratory biomarker analysis

Drug: talabostat mesylate

Biological: non-specific immune-modulator therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00489710

0401-05-FB

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

19 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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
Progressed after ≥ 1 multikinase inhibitor regimen (i.e., sorafenib tosylate or sunitinib malate)
No history of central nervous system or brain metastasis
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Absolute neutrophil count (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)
aspartate aminotransferase (AST) and alanine transaminase (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
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

Exclusion Criteria

History of CNS or brain metastasis
Pregnant, nursing or planning on becoming pregnant
Active serious infections
Malignancy within the past 5 years except basal cell or nonmetastatic squamous cell skin cancer or carcinoma in situ of the cervix
comorbidity or concurrent condition that would interfere with protocol assessments or procedures