Talabostat in Treating Patients With Metastatic Kidney Cancer

• Status: Withdrawn
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Enzyme Inhibitors

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