Bortezomib in Treating Patients With Metastatic Kidney Cancer (NCT00276614) | Clinical Trial Compass
CompletedPhase 2
Bortezomib in Treating Patients With Metastatic Kidney Cancer
United States4 participantsStarted 2006-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses