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Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer

2014-08-27 03:54:04 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- Determine the overall response rates in patients with stage IV clear cell renal cell carcinoma treated with vaccine comprising HLA-A2- and HLA-A3-binding peptides from fibroblast growth factor-5 emulsified in Montanide ISA-51. (Cohorts A and B)

- Determine the effect of this vaccine on the response rate to high-dose interleukin-2 in these patients. (Cohorts A and B)

- Determine the immunologic response in patients with stage III clear cell renal cell carcinoma at high risk for relapse treated with this vaccine. (Cohort C)

- Determine the toxicity of this vaccine in these patients.

Secondary

- Determine the immunologic response in patients with stage IV disease treated with this vaccine. (Cohorts A and B)

OUTLINE: Patients are stratified according to class I haplotype (HLA-A2 vs HLA-A3). Patients are assigned to 1 of 3 cohorts.

- Cohort A (no requirement for immediate interleukin-2 [IL-2] therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from fibroblast growth factor-5 (FGF-5) emulsified in Montanide ISA-51 subcutaneously (SC) once daily on days 1-4. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

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.

- Cohort B (requirement for immediate IL-2 therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from FGF-5 emulsified in Montanide ISA-51 SC once daily on days 1-4. Patients also 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 in the absence of disease progression or unacceptable toxicity.

- Cohort C: Patients receive peptide vaccination as in cohort A. At the time of relapse, patients have high-dose IL-2 added to their regimen as in cohort A. Treatment repeats every 15-19 days for up to 6 months 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

HLA-A2, A3-restricted FGF-5 peptides/Montanide ISA-51 vaccine, aldesleukin, adjuvant therapy

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
United States
20892-1182

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:04-0400

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