Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
110

Summary

Conditions
Neuroblastoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 18 years
Gender
Both males and females

Description

The phases of the study are: Screening phase: Tests and evaluations will be done before treatment starts. Induction phase: Includes chemotherapy plus hu14.18K322A mAb. Participants will also have surgery during this part of the study to remove as much tumor as possible. Consolidation/Intensification...

The phases of the study are: Screening phase: Tests and evaluations will be done before treatment starts. Induction phase: Includes chemotherapy plus hu14.18K322A mAb. Participants will also have surgery during this part of the study to remove as much tumor as possible. Consolidation/Intensification phase: Includes high doses of chemotherapy and blood stem cell transplantation with additional, experimental "minimal residual disease" (MRD) treatment. Participants will also get radiation treatment to all sites of the tumor(s) after recovery from the stem cell transplant. Maintenance/MRD treatment phase: With immune therapy in addition to the standard treatment with the drug isotretinoin.

Tracking Information

NCT #
NCT01857934
Collaborators
  • Cookies for Kids' Cancer
  • CURE Childhood Cancer, Inc.
Investigators
Principal Investigator: Wayne L. Furman, MD St. Jude Children's Research Hospital