This is an open-label, randomized phase II, single institution study comparing administration
of a 4-peptide melanoma vaccine alone or post-Ontak, in patients with metastatic melanoma.
Treatment:
1. Cohort A: Vaccine alone. Patients will receive immunization with an emulsion of 4
melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously
on day 1. A second vaccination will be given 2 weeks later and a third vaccination 2
weeks after that. Patients will be re-evaluated around week 6 and can continue courses
of 3 vaccinations (one every 2 weeks) until disease progression.
2. Cohort B: Ontak plus vaccine. Patients will receive Ontak (18 mcg/kg) intravenously on
day -4 for one dose. On day 0, they will receive the first immunization with an emulsion
of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected
intradermally/subcutaneously. A second vaccination will be given 2 weeks later and a
third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and
can continue courses of 3 vaccinations (one every 2 weeks) until disease progression.
However, no further Ontak will be given.
Duration: Patients may remain on study until disease progression, unacceptable toxicity,
patient choice to withdraw, or physician decision to discontinue therapy (due to intervening
illness, poor patient compliance, or other situation that would increase patient risk).
