Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515528
Status:
TERMINATED
Last Update Posted:
2021-01-26
First Post:
2007-08-09
Brief Title:
Vaccination Plus Ontak in Patients With Metastatic Melanoma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The immune monitoring data failed to demonstrate an improvement in any biologic endpoint with denileukin diftitox
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if 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 responses It is also hoped that this will lead to tumor shrinkage
Detailed Description:
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 eachGM-CSFMontanide injected intradermallysubcutaneously 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 mcgkg 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 eachGM-CSFMontanide injected intradermallysubcutaneously 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
Treatment
1 Cohort A Vaccine alone Patients will receive immunization with an emulsion of 4 melanoma peptides 250 mcg eachGM-CSFMontanide injected intradermallysubcutaneously 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 mcgkg 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 eachGM-CSFMontanide injected intradermallysubcutaneously 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None