Back to resultsPS-341 in Treating Patients With Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer
Eligibility 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
Sites / Locations
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Cancer Care Specialists of Central Illinois, S.C.
- Ingalls Memorial Hospital
- LaGrange Memorial Hospital
- Loyola University Medical Center
- Oncology/Hematology Associates of Central Illinois, P.C.
- Fort Wayne Medical Oncology and Hematology, Inc.
- Michiana Hematology/Oncology P.C.
- Oncology Care Associates, P.L.L.C.
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pre-Treatment biopsy followed by PS-341 administration
PS-341 administration followed by biopsy
Pre-treatment tumor biopsy followed by 3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects can continue to receive another 3 cycles of the study drug if their disease has not worsened.
3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects will have a tumor biopsy and can continue to receive another 3 cycles of the study drug if their disease has not worsened.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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