A Phase II Study Assessing a Vaccine in Combination with Beta-glucan and GM-CSF in People with Neuroblastoma

Full Title

Phase II Trial of a Bivalent Vaccine with the Immunological Adjuvant OPT-821 (QS-21), in combination with Oral ß-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining a “bivalent” vaccine with two agents that stimulate the immune system: a sugar called beta-glucan and a medication called GM-CSF. The treatment is designed to prevent the relapse of patients with high-risk neuroblastoma that is in complete remission. This bivalent vaccine works by stimulating an immune response against two different antigens, which are markers on the surface of a cell.

Researchers think this combination may be effective because the different parts of the treatment work to strengthen the immune system’s response against cancer cells in different ways. All patients will receive the vaccine and beta-glucan, but the GM-CSF will be randomly assigned so half of the patients will receive it and half will not. The vaccine and GM-CSF are given as injections and the beta-glucan is taken orally (by mouth).