Status:
COMPLETED
Bortezomib in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00276614
Start Date
April 1 2006
End Date
July 1 2009
Last Update
September 1 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781