NCT03033303View on ClinicalTrials.gov

A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

January 23, 2017

Primary Completion Date

September 29, 2025

Study Completion Date

September 29, 2025

Conditions
Neuroblastoma
Interventions
BIOLOGICAL

Hu3F8

Day 1: hu3F8 infused iv over \~30 to 90 minutes. Day 3: hu3F8 infused iv over \~30 to 90 minutes. Day 5: hu3F8 infused iv over \~30 to 90 minutes.

DRUG

GM-CSF

Days -4 to 0: GM-CSF 250 mcg/m2/day, subcutaneously. Days 1 to 5: GM-CSF 500 mcg/m2/day, subcutaneously.

DRUG

Isotretinoin

Isotretinoin is administered at 160 mg/m2/d, divided into two doses, x14 days.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

Y-mAbs Therapeutics
All Listed Sponsors
collaborator

Y-mAbs Therapeutics

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER