Bortezomib in Treating Patients With Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, papillary renal cell carcinoma
Eligibility 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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Experimental
Velcade
Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days