Vaccination Plus Ontak in Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00515528|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2007
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: 4-peptide melanoma vaccine Drug: 4-peptide melanoma vaccine plus Ontak Drug: ontak||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma|
|Actual Study Start Date :||April 23, 2007|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
4-peptide melanoma vaccine, ontak
Drug: 4-peptide melanoma vaccine
draftDrug: 4-peptide melanoma vaccine plus Ontak
Drug: 4-peptide melanoma vaccine plus Ontak
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515528
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Thomas Gajeweski, MD, PhD||University of Chicago|