Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT02320305
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-02
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:
This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.
Detailed Description:
PRIMARY OBJECTIVES:
I. Evaluate the immune response of each immunization regimen to determine an optimal regimen in terms of immune response to recommend for phase II testing.
SECONDARY OBJECTIVES:
I. Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
I. Describe the immunological efficacy of the vaccine preparations as measured by the frequency and interferon (IFN) gamma production of peptide-specific cytotoxic T lymphocytes (CTL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive MART-1 antigen and TLR4 antagonist GLA-SE intramuscularly (IM) on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, stage II patients are followed up at 10 weeks and then at 6, 12, 18, and 24 months and stage III-IV patients are followed up at 3, 6, 9, 12, 15, 18, 21, and 24 months.
I. Evaluate the immune response of each immunization regimen to determine an optimal regimen in terms of immune response to recommend for phase II testing.
SECONDARY OBJECTIVES:
I. Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
I. Describe the immunological efficacy of the vaccine preparations as measured by the frequency and interferon (IFN) gamma production of peptide-specific cytotoxic T lymphocytes (CTL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive MART-1 antigen and TLR4 antagonist GLA-SE intramuscularly (IM) on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, stage II patients are followed up at 10 weeks and then at 6, 12, 18, and 24 months and stage III-IV patients are followed up at 3, 6, 9, 12, 15, 18, 21, and 24 months.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-02479 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MC1177 | OTHER | Mayo Clinic | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |