drugset / Trial / NCT00003362

Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma

NCT00003362

RandomizedTreatment

Summary

RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating patients who have stage III or stage IV melanoma.

Timeline

Start
1998-05
Primary completion
2001-02
Completion
2001-02

Drugs

EvaluationDrugModalityDoseRoute
Subject QS-21 Other / unclassified Subcutaneous
Subject gp100 antigen Peptide Other
Subject sargramostim Protein / enzyme biologic Other
Subject tyrosinase peptide Peptide Other
Background incomplete Freund's adjuvant Other / unclassified

Indications