Vaccination Plus Ontak in Patients With Metastatic Melanoma
|Melanoma||Drug: 4-peptide melanoma vaccine Drug: 4-peptide melanoma vaccine plus Ontak Drug: ontak||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma|
- 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. [ Time Frame: draft ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
4-peptide melanoma vaccine, ontak
Drug: 4-peptide melanoma vaccine
draftDrug: 4-peptide melanoma vaccine plus Ontak
Drug: 4-peptide melanoma vaccine plus Ontak
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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515528
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Thomas Gajeweski, MD, PhD||University of Chicago|