drugset / Trial / NCT00019682

Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma

NCT00019682

Phase 3 Completed 185 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupSingle-blindTreatment

Summary

This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.

Timeline

Start
1999-12
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 720000 iu/kg Intravenous
Subject gp100:209-217(210M) Peptide Subcutaneous
Background incomplete Freund's adjuvant Other / unclassified Subcutaneous

Indications