RecruitingPhase 2NCT04936529

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

286 participants

Start Date

Aug 2, 2021

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma

Summary

The purpose of the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) as an effective treatment for people with high-risk neuroblastoma that is in complete remission. The 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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests a cancer vaccine combined with a molecule called beta-glucan (a natural immune booster) and GM-CSF (a growth factor for immune cells) to help children with high-risk neuroblastoma (an aggressive childhood cancer) stay in remission longer. **You may be eligible if...** - Your child has been diagnosed with high-risk neuroblastoma (a type of cancer found mostly in children, arising from nerve tissue) - Your child has achieved complete remission (no detectable cancer) after prior treatment - Your child's neuroblastoma meets international criteria for "high-risk" classification **You may NOT be eligible if...** - Your child's neuroblastoma is not high-risk - Your child is not in complete remission at the time of study entry - Your child has active, uncontrolled infection or other serious health conditions - Your child cannot tolerate the vaccine treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTβ-glucan

Group 1 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). This schedule includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at months 36 (3 years), 48 (4 years), and 60 (5 years). Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). Group 3 participants will be treated as in Group 1.

DRUGGM-CSF

Group 1 participants will not receive GM-CSF. Group 2 participants will receive GM-CSF (250 mcg/m2/day) x3 days with vaccinations #1-#3; x7 days with vaccinations #4-#11; and x5 days with vaccinations #12-#14. Group 3 participants will be treated as in Group 1.

BIOLOGICALOPT-821

Vaccine injections must occur a minimum of 6 days apart. After the first four vaccine injections, vaccines can be administered up to two weeks earlier or later than indicated without representing a protocol violation.