PS-341 in Treating Patients With Metastatic Kidney Cancer

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.

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