Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral ?-glucan for High-Risk Neuroblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Neuroblastoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 21 years
- Gender
- Both males and females
Description
The phase II treatment schema for patients in 1st CR or ? 2nd CR will be the same for the vaccine as in phase I except OPT-821 will be given at a fixed dose of 150 mcg/ m^2 and with no DLT assessment. Patients will be randomized to starting oral ?-glucan in week 1 or in week 6.
The phase II treatment schema for patients in 1st CR or ? 2nd CR will be the same for the vaccine as in phase I except OPT-821 will be given at a fixed dose of 150 mcg/ m^2 and with no DLT assessment. Patients will be randomized to starting oral ?-glucan in week 1 or in week 6.
Tracking Information
- NCT #
- NCT00911560
- Collaborators
- Y-mAbs Therapeutics, Inc
- Investigators
- Principal Investigator: Brian Kushner, MD Memorial Sloan Kettering Cancer Center