NCT03189706

Study of Chemoimmunotherapy for High-Risk Neuroblastoma

Phase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether an experimental drug called Hu3F8 can be given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF. The investigators want to find out if this combination is safe and what effect it has on the participant and the disease.

Conditions

• Neuroblastoma (NB)

Interventions

Type	Name	Description
DRUG	Irinotecan	50mg/m\^2/day IV will be administered from day 1-5
DRUG	temozolomide	(given concurrently with Irinotecan) 150mg/m\^2/day orally
BIOLOGICAL	Hu3F8	2.25mg/kg IV will be administered on days 2, 4, 8 and 10
DRUG	GM-CSF	250mcg/m2/day SC will be administered on days 6-10

Timeline

• Start date: 2017-06-12
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2017-06-16
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study