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Study of Chemoimmunotherapy for High-Risk Neuroblastoma

NCT03189706 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-02

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Shakeel Modak, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189706 on ClinicalTrials.gov