Randomized, Double Blind, Placebo-controlled Topical Resiquimod Adjuvant for NY-ESO-1 Protein Vaccination
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
The study is designed to see if a course of injections containing the NY-ESO-1 protein (a
tumor antigen, marker expressed by tumors); in combination with an immune stimulant
(adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and
safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC
criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to
see if the patient's body's defense (immune) system can be boosted (strengthened) by this
vaccine and if the addition of resiquimod to the vaccine makes this more likely.