drugset / Trial / NCT00003222

Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

NCT00003222

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.

Timeline

Start
1998-04
Primary completion
2003-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject gp100 antigen Peptide Intravenous
Subject sargramostim Protein / enzyme biologic Subcutaneous
Subject tetanus peptide melanoma vaccine Peptide Intravenous
Subject tyrosinase peptide Peptide Intravenous
Background aldesleukin Protein / enzyme biologic Subcutaneous
Background incomplete Freund's adjuvant Other / unclassified Subcutaneous

Indications