Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
OBJECTIVES: I. Compare the safety and immunogenicity of peptide 946 melanoma vaccine
(peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide
946-tetanus peptide conjugate in patients with high risk melanoma.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment
arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with
QS21 subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide
ISA-51 (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide
melanoma vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide
946 combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide
946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide
946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are
randomized to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities
are observed in these patients, then additional patients are randomized to arms III-VI.
Patients in each arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients
are followed at 6 and 12 months.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Primary Purpose: Treatment
Craig L. Slingluff, MD
University of Virginia
United States: Federal Government
|Cancer Center, University of Virginia HSC||Charlottesville, Virginia 22908|