Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124124
Status:
COMPLETED
Last Update Posted:
2015-02-13
First Post:
2005-07-25
Brief Title:
Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
Sponsor:
Dr Nina Bhardwaj
Organization:
Bhardwaj Nina MD
Study Overview
Official Title:
A Randomized Controlled Trial of Melanoma Treatment Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study a melanoma vaccine 5 melanoma peptides is given with either Montanide or dendritic cells as adjuvants This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses
Detailed Description:
In this study we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant
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