Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma
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).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune response and lead to tumor shrinkage.
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No
Thomas Gajeweski, MD, PhD
Principal Investigator
University of Chicago
United States: Food and Drug Administration
15232B
NCT00515528
June 2007
December 2012
Name | Location |
---|---|
University of Chicago | Chicago, Illinois 60637 |