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NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
Basic Trial Information
Summary 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. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Ludwig Institute for Cancer Research American Society of Clinical Oncology
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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