Tumors Clinical Trial
Official title:
Phase I Randomized, Double-blind, Placebo-controlled Study of Topical Resiquimod as an Adjuvant for NY-ESO1 Protein+Montanide Vaccination in Patients With Tumors That Often Express NY-ESO-1
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.
There is no published data on the application of topical resiquimod in combination with an
antigen in Montanide, therefore, this study includes a 2-part design where Part I represents
a dose-escalation part with topical resiquimod in an open-label fashion. Part II represents
the randomized part.
In Part I, 2 cohorts are planned: If no dose-limiting toxicity (DLT) occurs by day 8 of the
last vaccination cycle in the last patient enrolled the first cohort, 3 additional patients
(cohort 2) will be enrolled. If no DLT occurs by day 8 of the last vaccination cycle in the
last patient enrolled the second cohort in Part I, the trial will proceed to Part II where
patients will be randomized.
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