Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112216
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2005-05-31
Brief Title:
Immunotherapy of Melanoma Patients
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node
Status:
COMPLETED
Status Verified Date:
2009-03
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:
The purpose of this study is to test whether vaccination with antigenic peptides induces an immune response in the vaccine site sentinel lymph node of patients with microscopically detectable lymph node melanoma metastases
Detailed Description:
The study is designed for patients with skin melanoma and lymph node micrometastasis previously diagnosed by a sentinel node procedure As a result of their diagnosis the patients are scheduled for lymph node dissection Before this is done patients are vaccinated with antigenic peptides The peptides are mixed with the adjuvant SB AS-2 or Montanide and injected in a lower limb not affected by the disease The skin site of vaccine injection is marked with a permanent pen where two weeks later patent blue and 99technetium is injected These markers allow one to locate the vaccine site sentinel node VSSN which will be removed during the lymph node dissection at the diseased limb
The aim of the study is to test whether the vaccine has induced an immune response in the lymph node that drains the vaccine site
The aim of the study is to test whether the vaccine has induced an immune response in the lymph node that drains the vaccine site
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