Bortezomib in Treating Patients With Metastatic Kidney Cancer

Completed · Phase 2

Conditions studied: Kidney Cancer

In brief

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.

Key facts

Study ID

NCT00276614

Run by

Jonsson Comprehensive Cancer Center

People needed

4

Starts

2006-04-01

Expected to finish

2009-07-01

Last updated by the study team

2020-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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