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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00126490 |
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 |
---|---|---|
Kidney Cancer |
Drug: aldesleukin Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer |
Estimated Enrollment: | 38 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 3 months for at least 2 years.
PROJECTED ACCRUAL: Approximately 10-38 patients will be accrued for this study within 21 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 cancer
Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the following criteria:
Calcium normal (corrected)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following arterial thromboembolic events within the past 6 months:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 10 days since prior anticoagulants
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 |
Principal Investigator: | Mayer Fishman, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000434852, MCC-13921, MCC-IRB-102782, NCI-6438 |
Study First Received: | August 2, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00126490 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Urogenital Neoplasms Bevacizumab 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 Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents |