Bortezomib in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.

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

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Millennium Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)

• Distant metastatic disease (Tx, Nx, M1)

• Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein

• Measurable disease on imaging scan (≥ 1 cm)

• Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy.

• Life expectancy ≥ 3 months

• Karnofsky performance status ≥ 60%

• Negative pregnancy test

• Fertile patients must use an acceptable method of contraception

• No other major illnesses likely to limit survival

• Platelet count ≥ 100,000/mm^3

• Absolute neutrophil count ≥ 1, 000/mm^3

• Hemoglobin ≥ 10 g/dL (transfusion allowed)

• Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL

• ALT or AST ≤ 2.5 times upper limit of normal

• At least 4 weeks since prior radiotherapy and recovered

• More than 30 days since any other prior investigational drugs

Exclusion Criteria:

• active CNS metastases

• pregnant or nursing

• myocardial infarction within the past 6 months

• New York Heart Association class III or IV heart failure

• uncontrolled angina

• severe uncontrolled ventricular arrhythmias

• electrocardiographic evidence of acute ischemia or active conduction system abnormalities

• Peripheral neuropathy ≤ grade 1

• hypersensitivity to bortezomib, boron, or mannitol

• history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin

• serious medical or psychiatric illness that would preclude study participation

• prior cytotoxic chemotherapy for this cancer

• other concurrent investigational therapy

• concurrent chemotherapy, immunotherapy, or hormonal therapy