PS-341 in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic renal cell cancer

• Measurable disease

• At least 2.0 cm in at least 1 dimension by physical exam OR at least 1.0 cm in at least 1 dimension by radiologic exam

• Single measurable lesion must not be within prior radiotherapy portal

• Tumor lesion amenable to core biopsy

• At least 1 cm of tumor obtainable

• No active CNS metastatic disease

• Single previously resected CNS metastasis allowed provided no disease progression 8 weeks after therapy and no longer requiring steroids or antiseizure medications

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

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 times upper limit of normal (ULN)

• AST/ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other:

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier-method contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior immunotherapy or biotherapy allowed

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to 25% or more of bone marrow (i.e., whole pelvis)

Surgery:

• See Disease Characteristics

Other:

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients