drugset / Trial / NCT01079741

Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

NCT01079741

RandomizedParallel-groupOpen-labelTreatment

Summary

The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.

Timeline

Start
2010-09
Primary completion
2013-03-11
Completion
2013-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hiltonol Other / unclassified 0.35 mg Subcutaneous
Subject Hiltonol Other / unclassified 1.4 mg Subcutaneous
Subject Montanide Other / unclassified 1.1 ml
Subject NY-ESO-1 Protein / enzyme biologic 100 ug Subcutaneous

Indications