Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
OBJECTIVES:
Primary
- Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine
administered subcutaneously in patients with androgen-independent metastatic prostate
cancer.
Secondary
- Compare the response induced by immunotherapy with a combined class-I and class-II
NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides
alone.
- Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in
a better antitumor immune response than class-I epitopes alone.
- Determine antitumor activity by antigen response assays including cytokine elaboration,
changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral
cellular infiltrates and cytokine expression in responding and nonresponding
metastasis.
OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week
for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial
cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class
II-binding peptides. If these Class I or Class II binding peptides are safe individually,
subsequent cohorts of patients with appropriate HLA type receive both types of peptides in
combination.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
Interventional
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability
Yes
Teresa G. Hayes, MD, PhD
Study Chair
Veterans Affairs Medical Center - Houston
United States: Food and Drug Administration
CDR0000579579
NCT00616291
April 2006
July 2011
Name | Location |
---|---|
Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston, Texas 77030 |