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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00032188 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: aldesleukin Drug: bryostatin 1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Study Of Interluekin-2 In Combination With Three Different Doses Of Bryostatin In Patients With Renal Cell Carcinoma |
Study Start Date: | February 2002 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma
No active CNS metastases
Single prior CNS metastasis allowed if all of the following are true:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
LaGrange Memorial Hospital | |
LaGrange, Illinois, United States, 60525 | |
Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Michigan | |
Oncology Care Associates, P.L.L.C. | |
Saint Joseph, Michigan, United States, 49085 |
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000069267, UCCRC-11367, UCCRC-NCI-5550, NCI-5550 |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00032188 |
Health Authority: | United States: Federal Government |
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Urogenital Neoplasms Bryostatin 1 Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Aldesleukin |
Urologic Diseases Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic |
Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses |