Bortezomib in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment. Secondary Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity. OUTLINE: This is an open-label study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month and then periodically for 2 years. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Official Title
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A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Velcade<br>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 | Drug: bortezomib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer, papillary renal cell carcinoma