Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313508
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2006-04-11
Brief Title:
Dendritic Cell Vaccination During Lymphoid Reconstruction
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Dose Ranging Trial of MART-1gp100TyrosinaseNY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines With Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2012-12
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 is a randomized controlled multicenter dose-escalation study of fludarabine Patients are randomized to 1 of 2 treatment arms
The purpose of this study is to find out what side effects are caused in this study and whether Fludarabine with the dendritic cell vaccine DC vaccine can increase the ability of the immune system to recognize melanoma
The purpose of this study is to find out what side effects are caused in this study and whether Fludarabine with the dendritic cell vaccine DC vaccine can increase the ability of the immune system to recognize melanoma
Detailed Description:
This is a dose ranging study of intranodal administration of autologous dendritic cells DC pulsed with tumor antigen class I peptides derived from MART-1 26-35 27L gp100 209-217 210M gp100 280-288 288V NY-ESO-1 157-165 165V and tyrosinase 207-215 as well as class II MART-1 51-73 NY-ESO-1 119-143 MAGE-3 243-258 and tyrosinase 450-462 peptides preceded by Autologous Lymphocyte Infusion ALI and one of two doses of Fludarabine The nine or ten amino acid peptides representing HLA-A2 restricted T cell epitopes of MART-1 gp100 NY-ESO-1 and tyrosinase will be pulsed onto autologous dendritic cells produced by incubation of peripheral blood mononuclear cells obtained by apheresis with interleukin-4 IL-4 and GM-CSF and pulsed with four helper peptides then matured with a cytokine cocktail including TNF-a IL-6 IL-1b and PGE2 Melanoma antigen peptide-pulsed dendritic cells will be administered at a total dose of 10 million cells each for four intranodal injections to patients with chemotherapy-naïve metastatic melanoma
DC matured with a cytokine cocktail and pulsed with class I and II peptides will be injected intranodally weekly for two doses then every two weeks for two doses for a total of four injections to each cohort
DC matured with a cytokine cocktail and pulsed with class I and II peptides will be injected intranodally weekly for two doses then every two weeks for two doses for a total of four injections to each cohort
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 |
|---|---|---|---|
| NCI-6241 | OTHER | NCI Protocol Number | None |