A Vaccine Study for High Risk Cancers
|ClinicalTrials.gov Identifier: NCT00944580|
Recruitment Status : Withdrawn (unexpectedly low screening results leading to poor accrual)
First Posted : July 23, 2009
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Rhabdomyosarcoma Osteogenic Sarcoma||Biological: MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine||Phase 1|
MAGE -A1, MAGE- A3, and NY-ESO-1 are antigens that can be found with significant frequency on neuroblastoma, rhabdomyosarcoma, and osteogenic sarcoma, three relatively common solid tumors that in some cases can be associated with a high risk for relapse. In this study each subject will be screened for the presence of these antigens, and an individualized vaccine will be developed and administered using the subject's own dendritic cells (DC).
This study consists of two phases: a screening phase and a treatment/vaccine phase. First, eligible individuals will be consented into the screening phase. Tumor specimens will be tested by immunohistochemistry or RT-PCR for the presence of MAGE- A1, MAGE- A3, and NY-ESO-1. Those testing positive for one or more antigen can be consented for the treatment phase of the study. Blood will be drawn for DC culture, and approximately one month later a series of three vaccines will be administered at two week intervals. Subjects will receive a topical medication called imiquimod to the vaccine site prior to and following each injection, to help immune cells travel into the area. Study participation occurs over 18 months and also involves periodic physical examinations and blood draws.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study to Determine the Immunologic Effects of a MAGE- A1, MAGE- A3, NY-ESO-1 Vaccine in Patients With High Risk Neuroblastoma, Osteogenic Sarcoma, and Rhabdomyosarcoma|
|Study Start Date :||June 2009|
|Primary Completion Date :||August 2010|
|Study Completion Date :||August 2010|
Experimental: Vaccine Intervention
MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine: A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.
Biological: MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine
A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.
- The primary objective is to determine if there is an amplification or new development of NY-ESO-1, MAGE-A1, or MAGE-A3 specific CD4+ or CD8+ T cells post-vaccination. [ Time Frame: 2 years ]
- The investigators will determine the safety of vaccine and imiquimod administration in these patients. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944580
|Study Chair:||Kenneth G. Lucas, MD||Milton S. Hershey Medical Center|