drugset / Trial / NCT01264731

Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma

NCT01264731

Phase 1 Completed 4 enrolled University of Virginia
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine 1) the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.

Timeline

Start
2011-01
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imiquimod Other / unclassified 5 % Topical
Comparator Imiquimod Other / unclassified 250 mg Topical
Comparator MELITAC 12.1 Vaccine 100 ug Subcutaneous
Comparator MELITAC 12.1 Vaccine 200 ug Subcutaneous

Indications