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Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced 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 Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer Clinical research trials and Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced 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 Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced 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 Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced 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 > "I" Clinical Trials Conditions > Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer  Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
For Condition: stage 3 renal cell cancer,stage 4 renal cell cancer,recurrent renal cell cancer
Status: Suspended
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer.
Details: OBJECTIVES: - Determine the objective response rate in patients with advanced renal cell carcinoma treated with interleukin-2 (IL-2) and bryostatin 1. - Compare the toxicity of 3 different doses of bryostatin 1 given in combination with a fixed dose of IL-2 in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three dose levels of bryostatin 1. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-4, 8-11, and 15-18. For the second and subsequent courses of IL-2, patients also receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 3 additional courses of therapy. An additional cohort of patients receives treatment as above at a higher dose to evaluate toxicity. Patients are followed for 1 year. PROJECTED ACCRUAL: A total of 24-65 patients (8-16 per bryostatin 1 dose level) will be accrued for this study within 14-27 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed renal cell carcinoma - Recurrent or refractory advanced disease OR - Newly diagnosed disease with no appropriate standard therapy available - Measurable disease - No active CNS metastases - Single prior CNS metastasis allowed if all of the following are true: - Previously resected and irradiated - No evidence of progressive CNS disease for at least 8 weeks after completion of therapy - No requirement for steroids or anti-seizure medications PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 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: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and for 3 months after study for male patients - No concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior interleukin-2 Chemotherapy: - Not specified Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - Prior radiotherapy to less than 50% of bone marrow allowed - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, University of Chicago Cancer Research Center
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000069267; UCCRC-NCI-5550,NCI-5550,UCCRC-11367
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032188
Other Stage 3 Renal Cell Cancer Studies:
1. Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
2. High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
3. Interferon alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
4. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
5. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
Related Studies:
Other stage 3 renal cell cancer Clinical Trials
Other Indiana Clinical Trials
Other South Bend Clinical Trials
Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
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