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PS-341 in Treating Patients With Metastatic Kidney Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about PS-341 in Treating Patients With Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. PS-341 in Treating Patients With Metastatic Kidney Cancer Clinical research trials and PS-341 in Treating Patients With Metastatic Kidney Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as PS-341 in Treating Patients With Metastatic Kidney Cancer. PS-341 in Treating Patients With Metastatic Kidney Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a PS-341 in Treating Patients With Metastatic Kidney Cancer clinical trial. Subjects often receive the most expert healthcare possible for their PS-341 in Treating Patients With Metastatic Kidney Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > PS-341 in Treating Patients With Metastatic Kidney Cancer  PS-341 in Treating Patients With Metastatic Kidney Cancer
PS-341 in Treating Patients With Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the objective response rate in patients with metastatic renal cell cancer treated with PS-341. II. Determine the time to tumor progression and 1-year survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo core biopsy. Arm II: Patients undergo core biopsy. Patients then receive PS-341 IV as in arm I. Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable disease or a partial or complete response continue to receive PS-341 in the absence of disease progression or unacceptable toxicity. Patients are followed for 2 years. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- Age: 18 and over Performance status: Not specified Life expectancy: More than 3 months Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 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 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier-method contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, University of Chicago Cancer Research Center
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Additional Information:
Study ID Numbers: CDR0000068955; NCI-3291,UCCRC-11049A
Study Start Date: October 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025376
Other Recurrent Renal Cell Cancer Studies:
1. Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
2. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
3. SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
4. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
5. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Indiana Clinical Trials
Other Ft. Wayne Clinical Trials
PS-341 in Treating Patients With Metastatic Kidney Cancer
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