A Pilot Study To Access The Immunologic Response To Booster Vaccination With A Modified gp100 Melanoma Peptide (209-2M) Vaccine In Previously Vaccinated HLA-A2.1+ Patients With Melanoma
- Determine the toxicity of booster vaccination with gp100:209-217 (210M) peptide and
HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 administered at least
12 months after prior vaccination in patients with melanoma.
- Determine T-cell response to modified gp100: 209-217 (210M) peptide and unmodified
native gp100 peptide in these patients.
- Determine T-cell response to the control HLA-A2-restricted CD8 epitope of HPV-16 E7
(12-20) peptide vaccine in these patients.
OUTLINE: Patients undergo leukapheresis on day 0. Patients receive vaccination comprising
gp100:209-217 (210M) and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51
subcutaneously (SC) on day 1 and between days 25-30 in the absence of disease progression or
unacceptable toxicity. Patients undergo a second leukapheresis 2-4 weeks after the second
Patients who remain disease free for 6 months after the second vaccination may receive
additional booster vaccinations SC every 6 months for 3 years.
Patients are followed at 3 and 6 months after the second vaccination and then every 6 months
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.
Masking: Open Label, Primary Purpose: Treatment
Walter J. Urba, MD, PhD
Providence Cancer Center, Earle A. Chiles Research Institute
United States: Federal Government
|Earle A. Chiles Research Institute at Providence Portland Medical Center||Portland, Oregon 97213-2967|