Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma
- Determine the safety of a peptide vaccine comprising MART-1:27-35 peptide,
gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG
7909 emulsified in incomplete Freund's adjuvant in patients with unresectable recurrent
stage III or IV melanoma.
- Determine the efficacy of immunoadjuvants CpG 7909 and GM-CSF, in terms of a strong
antigen-specific CD8+ T-cell response, in these patients.
- Determine the anti-pigmentary response to this regimen in these patients.
- Determine the anti-tumor response, in terms of objective tumor regression,
progression-free survival, and overall survival, in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M)
peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in
incomplete Freund's adjuvant subcutaneously on days 1 and 15. Treatment repeats every 28
days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, day 50-53, and day 91-94. Samples are examined by
ELISPOT assay to measure lymphocyte immune response and by flow cytometry for biomarker
quantification and T-cell response.
After completion of study treatment, patients are followed up periodically for at least 2
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Ahmad A. Tarhini, MD, MS
University of Pittsburgh
United States: Food and Drug Administration
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|