Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01425749
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2011-07-19
Brief Title:
Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI
Sponsor:
Craig L Slingluff Jr
Organization:
University of Virginia
Study Overview
Official Title:
T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 AS15 Immunological Adjuvant System
Status:
COMPLETED
Status Verified Date:
2016-03
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:
Mel55
Brief Summary:
The goals of this study are to 1 assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System recMAGE-A3 AS15 as an Antigen-Specific Cancer Immunotherapeutic MAGE-A3 ASCI when administered in two different administration sites intramuscular IM or intradermalsubcutaneous IDSC and 2 to provide preliminary data on the immunological response to ASCI in the injection site microenvironment in the node draining the vaccine site sentinel immunized node and in the blood and whether there are large differences in the magnitude persistence or type of immune response induced as a function of the ASCI injection Evaluation of immune responses to the ASCI will include amonth others antiMAGE-A3 antibody responses and CD4 and CD8 T cell responses
Detailed Description:
This was an open-label randomized single institution pilot study to evaluate the safety and immunologic response to MAGE-A3 immunotherapeutic administered by either of two injection routes im or idsc Patients were studied following IRB approval IRB 15398 and documentation of informed consent The trial was registered in clinicaltrialsgov NCT01425749 and was performed at the University of Virginia
MAGE-A3 immunotherapeutic 05 ml was administered five times weeks 0 3 6 9 12 in extremities uninvolved with melanoma Vaccines 1 and 3 were administered at the same site other vaccine sites were rotated among available extremities Subjects were randomized 11 within each stratum AJCC stage IIIII or IV to im Group A or idsc Group B administration The randomization code was generated by the study statistician using varying block sizes of 2 to 4 For group B patients half of the dose was injected sc then the needle was withdrawn to the dermis then advanced intradermally from that same puncture site and the remaining half dose was injected id Immune responses were evaluated in a SIN and PBMC
MAGE-A3 immunotherapeutic 05 ml was administered five times weeks 0 3 6 9 12 in extremities uninvolved with melanoma Vaccines 1 and 3 were administered at the same site other vaccine sites were rotated among available extremities Subjects were randomized 11 within each stratum AJCC stage IIIII or IV to im Group A or idsc Group B administration The randomization code was generated by the study statistician using varying block sizes of 2 to 4 For group B patients half of the dose was injected sc then the needle was withdrawn to the dermis then advanced intradermally from that same puncture site and the remaining half dose was injected id Immune responses were evaluated in a SIN and PBMC
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