Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028431
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2002-01-04
Brief Title:
Novel Adjuvants for Peptide-Based Melanoma Vaccines
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
An Open Label Study of MDX-CTLA4 in Combination With Tyrosinasegp100MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody tyrosinase gp100 and MART-1 peptides and incomplete Freunds adjuvant IFA with or without interleukin-12 in patients with resected stage III or IV melanoma
Detailed Description:
In the Phase III trial patients with resected stages III and IV melanoma who have been rendered free of disease but are at high risk of relapse are treated with peptidesIFA at a dose of 05 mg each peptide plus CTLA-4 antibody given intravenously 3 mgkg after each vaccination In the Phase II randomized study patients are treated with the melanoma peptide vaccine alone with CTLA-4 antibody or with CTLA-4 antibody combined with IL-12 at 30 ngkg with alum The peptides are tyrosinase 368-376 370D gp100 209-217 210M and MART-1 26-35 27L which are emulsified with IFA The dosing schedule for both trials are at 1 2 3 4 5 and 6 months then at 9 and 12 for a total of 8 vaccinations
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-001975-01 | None | None | None |
| 10M-00-4 | None | None | None |