Recurrent Melanoma Clinical Trial
Official title:
A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma
This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PRIMARY OBJECTIVES:
I. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide
vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG
administered >= 12 months after the last immunization.
II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the
unmodified native gp100 peptide following booster vaccination >= 12 months after the last
immunization.
III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2
restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20
following booster vaccination >= 12 months after the last immunization.
IV. To perform detailed studies of the memory T cells persisting >= 12 months after
immunization.
OUTLINE:
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine
with Montanide ISA 51 VG or Montanide ISA 51 subcutaneously (SC) on day 1 and between days
25-30. After 6 months, patients free of disease receive booster injections every 6 months
for 3 years in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed up at 6 months, every 6 months
for 5 years, and then annually thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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