Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.


Study summary:

OBJECTIVES: - Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma. - Determine the safety of this drug in these patients. OUTLINE: This is an open-label study. Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma - Metastatic disease - Unidimensionally measurable disease - No brain metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Karnofsky 70-100% Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: - Creatinine no greater than 1.5 times ULN Other: - No pre-existing neuropathy of grade 1 or greater - No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy and recovered - No concurrent biologic therapy Chemotherapy: - No prior cytotoxic therapy - No concurrent cytotoxic therapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - At least 4 weeks since prior major surgery Other: - No other concurrent anticancer therapy


NCT ID:

NCT00017329


Primary Contact:

Study Chair
Beverly Drucker, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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