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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091403 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: HLA-A2, A3-restricted FGF-5 peptides/Montanide ISA-51 vaccine Drug: aldesleukin Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Immunization of Patients With Renal Cancer Using HLA-A2 and HLA-A3-Binding Peptides From Fibroblast Growth Factor 5 (FGF-5) |
Estimated Enrollment: | 210 |
Study Start Date: | August 2004 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to class I haplotype (HLA-A2 vs HLA-A3). Patients are assigned to 1 of 3 cohorts.
At the time of disease progression, patients eligible for IL-2 who have not yet received it have high-dose IL-2 added to their regimen. Patients continue to receive peptide vaccination on days 1-4 and receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year of total treatment.
Patients are followed every 3-6 months (cohorts A and B) OR every 3 months for 1 year and then every 6-12 months thereafter (cohort C).
PROJECTED ACCRUAL: A total of 36-210 patients (12-80 in cohort A, 12-66 in cohort B, and 12-64 in cohort C) will be accrued for this study within 5 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed clear cell renal cell carcinoma meeting one of the following criteria:
Measurable metastatic disease (cohorts A and B)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No known immunodeficiency disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | James C. Yang, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000386241, NCI-04-C-0259, NCI-6622 |
Study First Received: | September 7, 2004 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00091403 |
Health Authority: | United States: Food and Drug Administration |
stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Aldesleukin Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Site Neoplasms by Histologic Type |
Anti-Retroviral Agents Antineoplastic Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |