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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301990 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: aldesleukin Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study |
Estimated Enrollment: | 65 |
Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (good vs intermediate vs poor).
Patients receive bevacizumab IV over 30-90 minutes on days -13, 1, 15, 29, 43, 57, and 71 during course 1 and on days 1, 15, 29, 43, 57, and 71 during courses 2 and 3. Patients also receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19. Treatment repeats every 84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
FEV_1 ≥ 2.0 L or ≥ 75% of predicted
No evidence of any of the following cardiac conditions*:
No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cancer, such as cervical carcinoma in situ, superficial bladder cancer without local recurrence, or breast cancer in situ
No history of inflammatory bowel disease or other serious autoimmune disease
PRIOR CONCURRENT THERAPY:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202-5289 | |
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
United States, New Hampshire | |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756-0002 | |
Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
United States, New York | |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Recruiting |
Bronx, New York, United States, 10466 | |
Contact: Janice P. Dutcher, MD 718-304-7200 | |
United States, Oregon | |
Providence Cancer Center at Providence Portland Medical Center | Recruiting |
Portland, Oregon, United States, 97213-2967 | |
Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
United States, Virginia | |
University of Virginia Cancer Center | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Geoffrey R. Weiss, MD 434-243-0066 grw3k@virginia.edu |
Study Chair: | Fairooz F. Kabbinavar, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000460074, UCLA-050658-01, DMS-W0454 |
Study First Received: | March 10, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00301990 |
Health Authority: | Unspecified |
stage IV renal cell cancer recurrent renal cell cancer clear cell renal cell carcinoma |
Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Aldesleukin Urologic Diseases |
Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |