NCT01425749

Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI

T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 + AS15 Immunological Adjuvant System

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Craig L Slingluff, Jr · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 intradermal/subcutaneous (ID/SC), 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 (i.m. or i.d./s.c.). Patients were studied following IRB approval (IRB #15398) and documentation of informed consent. The trial was registered in clinicaltrials.gov (NCT01425749), and was performed at the University of Virginia. MAGE-A3 immunotherapeutic (0.5 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 1:1, within each stratum (AJCC stage II/III or IV), to i.m. (Group A) or i.d./s.c. (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 For group B patients, half of the dose was injected s.c., then the needle was withdrawn to the dermis, then advanced intradermally from that same puncture site and the remaining half dose was injected i.d. Immune responses were evaluated in a SIN and PBMC.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	recMAGE-A3 + AS15 ASCI	Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-07-01
• Completion: 2015-10-01
• First posted: 2011-08-30
• Last updated: 2016-04-04
• Results posted: 2016-04-04

Locations

1 site across 1 country: United States