NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
This study evaluates a cancer vaccine in melanoma patients who have resected melanoma but are at high risk for recurrence (stages IIB-III). This is a single arm, open label, pilot/phase I study evaluating safety and immunogenicity of NY-ESO-1 protein vaccination with Imiquimod as an adjuvant.
Imiquimod is a FDA approved immune response modifier for the treatment of HPV associated genital warts (but used for a different indication here) and has been shown to attract and mature dendritic cells in areas of topical application. This will be utilized in this application to inject a protein vaccine into this site, to prime and boost anti-NY-ESO-1 immune responses.
9 patients will be treated to receive 4 vaccination cycles, 21 days apart. Each vaccination cycle consists of topical application of Imiquimod 250mg to healthy skin of extremities for the first five days of each cycle and intradermal injection of NY-ESO-1 protein 100mcg to the pretreated area on day 3.
Immunization will be assessed by T-cell assays, NY-ESO-1 specific antibody titers, and evaluation of 3 small skin biopsies.
Biological: NY-ESO-1 protein
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant|
|United States, New York|
|NYU Cancer Institute|
|New York City, New York, United States, 10016|
|Principal Investigator:||Nina Bhardwaj, MD, PhD||New York University School of Medicine|
|Study Director:||Sylvia Adams, MD||New York University School of Medicine|