Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.
|Melanoma (Skin)||Biological: OVA BiP peptide Biological: gp209-2M antigen Biological: recombinant 70-kD heat-shock protein Biological: tyrosinase peptide||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Vaccination of Melanoma Patients With Tyrosinase YMD and gp100 IMD-Javelin Fusion Peptides/HSP70 Complexes: A Trial Comparing the Immunogenicity of Three Doses|
|Study Start Date:||June 1999|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine whether active specific immunization comprising tyrosinase and gp100:209-217 (gp100) peptides fused with OVA BiP peptide and heat shock protein 70 (HSP70) induces immunity against tyrosinase and gp100 in HLA-A2 positive patients with stage III or IV melanoma. II. Determine the lowest optimally immunogenic dose of tyrosinase and gp100 in these patients. III. Determine the tolerability of this regimen in these patients.
OUTLINE: This is a dose escalation study of tyrosinase and gp100:209-217 antigen (gp100). Patients receive vaccination comprising tyrosinase and gp100 fused with OVA BiP peptide and heat shock protein 70 (HSP70) subcutaneously on weeks 0, 1, 2, 6, and 18 for a total of 5 vaccinations in the absence of disease progression or unacceptable toxicity. Cohorts of 9 patients receive escalating doses of tyrosinase and gp100 until the lowest optimally immunogenic dose is determined. The lowest optimally immunogenic dose is defined as the dose at which 4 or more of 9 patients demonstrate T-cell responses.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005633
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Philip O. Livingston, MD||Memorial Sloan Kettering Cancer Center|