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COMPLETED
NCT03033303
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.

Official title: Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2017-01-23

Completion Date

2025-09-29

Last Updated

2026-10-30

Healthy Volunteers

No

Conditions

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.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States