drugset / Trial / NCT01307618

Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma

NCT01307618

Phase 2 Terminated 10 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells. Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may decrease the number of regulatory T cells (T cells that suppress the activation of the immmune system) and may lead to a better immune response against melanoma. It is not yet known whether vaccine therapy is more effective with interleukin-12 and daclizumab in treating melanoma.

Timeline

Start
2011-02
Primary completion
2015-01
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject MART-1 antigen Vaccine Subcutaneous
Subject MELANOMA-ASSOCIATED ANTIGEN 3 Protein / enzyme biologic Subcutaneous
Subject NA17.A2 Peptide Subcutaneous
Subject interleukin-12 Protein / enzyme biologic Subcutaneous

Indications