Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160992
Status:
SUSPENDED
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients
Sponsor:
University of Lausanne Hospitals
Organization:
University of Lausanne Hospitals
Study Overview
Official Title:
Phase I Study of in Vivo Expansion of Melan-AMART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma
Status:
SUSPENDED
Status Verified Date:
2005-09
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:
Patients with advanced stage melanoma who underwent vaccination with the Melan-AMART-1 peptide and who display detectable levels of Melan-A specific CD8 T cells in peripheral blood are eligible for this trial After collecting and freezing of these tumor specific T cells via apheresis patients undergo a single cycle of immunosuppressive chemotherapy 3 days after cells are reinfused and peptide vaccination continued The aim of this immunotherapy protocol is to boost tumor specific T cells during the immune recovery period in order to reinforce the patients immune response against the tumor
Detailed Description:
Patients who have previously been vaccinated with Melan-AMART-1 peptide are eligible Whole PBMCs containing Melan-A specific CD8 lymphocytes are collected via lymphocytapheresis and freezed Lymphodepleting chemotherapy consists of 2 days of Busulfan 2mgkg at days -7-6 followed by Fludarabine 30mgm2 at days -5-4-3 At day 0 whole untreated PBMCs are reinfused to the patient and vaccination with Melan-A analog peptide is restarted and repeated every 4 weeks Immunomonitoring with detailed FACS analysis using tetramers is performed at day 081530 and then monthly The aim is to boost Melan-A specific CD8 T cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven proliferation due to peptide vaccination
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