Neuroblastoma Clinical Trial
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
The purpose of this study is to determine the safety and immunological effects of a vaccine for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma. It is hypothesized that this vaccine could reduce the incidence of relapse.
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.
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