Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma
- Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope
melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF)
in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in
patients who have undergone surgical resection for stage II-IV melanoma.
- Determine, preliminarily, the immunogenicity of these regimens in these patients.
- Correlate, preliminarily, transdermal administration of these vaccines with the
recruitment and maturation of epidermal Langerhans cells in these patients.
- Determine, preliminarily, the effects of timing of subsequent vaccine therapy
comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered
intradermally and subcutaneously, on the persistence of immune response in these
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment
- Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides
(MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in
Montanide ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the
vaccine intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and
- Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod
topically on days 0, 7, and 14.
- Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl
sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP,
TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113,
- Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.
In all arms, treatment continues in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed at 3 and 5 weeks and then at
PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be
accrued for this study within approximately 2 years.
Masking: Open Label, Primary Purpose: Treatment
Safety if less than 33% of patients experience a dose-limiting at day 22
Craig L. Slingluff, MD
University of Virginia
United States: Federal Government
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|