Using a Vaccine and Beta-glucan to Help Children with Neuroblastoma

Recruiting · Phase 2 · Neuroblastoma and related conditions · New Jersey and New York

Check if I qualify View on ClinicalTrials.gov

About this trial

This study is looking at how well a vaccine and a substance called β-glucan work together for people with high-risk neuroblastoma who are in complete remission. The goal is to find the best treatment schedule for this combination. Neuroblastoma is a type of cancer that mostly affects children.

This is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and plans to include about 94 participants.

Who can join

Both children and adults can join. Participants should have high-risk neuroblastoma and be in complete remission for at least 6 months after starting immunotherapy. They must not have serious health issues or allergies related to the treatment. A negative pregnancy test is required for those who can become pregnant. The trial team will confirm who is eligible.

Conditions

Neuroblastoma, High-risk Neuroblastoma, Metastatic Neuroblastoma

Age group

All ages

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be placed into two groups. Group 1 will receive oral β-glucan for 14 days on and 14 days off, starting with the first vaccination and continuing until the fifth vaccination. Group 2 will have the same β-glucan treatment but will continue until the seventh vaccination. All participants will also receive a vaccine called OPT-821.