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Cancer Vaccine

Hu3F8 + GM-CSF + Isotretinoin for Neuroblastoma

Phase 2
Waitlist Available
Led By Brian H. Kushner, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be in first CR/VGPR
Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age)
Must not have
Active life-threatening infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing the effects of a drug called Humanized 3F8 (Hu3F8) when used in combination with another drug called granulocyte-macrophage colony stimulating factor (GM-CSF). The trial is testing to see if this combination can prevent neuroblastoma from growing, but it could also cause side effects.

Who is the study for?
This trial is for patients with high-risk neuroblastoma, which includes certain stages of the disease and specific age groups. Participants must have a negative antibody test against Hu3F8 and be in their first complete or very good partial remission. They can't join if they have severe organ dysfunction, active serious infections, or can't follow the study plan.
What is being tested?
The study is looking at how well Humanized 3F8 (Hu3F8) works when combined with GM-CSF to prevent neuroblastoma from growing back after initial treatment success. Patients will also receive Isotretinoin as part of their therapy regimen.
What are the potential side effects?
Possible side effects include reactions related to immune activation by Hu3F8 such as inflammation, potential discomfort at injection sites due to GM-CSF, and skin-related issues like dryness or peeling from Isotretinoin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is in its first complete or very good partial response.
Select...
My neuroblastoma is high-risk, either due to MYCN amplification or being over 18 months with stage 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a severe infection that is threatening my life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
relapse-free survival (RFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hu3F8/GM-CSF Plus IsotretinoinExperimental Treatment3 Interventions
In this phase II single arm trial, patients with HR-NB in first CR or VGPR undergo consolidation by using hu3F8/GM-CSF x5 cycles and isotretinoin x6 cycles. Isotretinoin starts after cycle 2 of hu3F8/GM-CSF.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340
Isotretinoin
2019
Completed Phase 4
~3520

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,497 Total Patients Enrolled
50 Trials studying Neuroblastoma
5,777 Patients Enrolled for Neuroblastoma
Y-mAbs TherapeuticsIndustry Sponsor
25 Previous Clinical Trials
1,498 Total Patients Enrolled
12 Trials studying Neuroblastoma
1,133 Patients Enrolled for Neuroblastoma
Brian H. Kushner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
430 Total Patients Enrolled
6 Trials studying Neuroblastoma
430 Patients Enrolled for Neuroblastoma

Media Library

GM-CSF (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03033303 — Phase 2
Neuroblastoma Research Study Groups: Hu3F8/GM-CSF Plus Isotretinoin
Neuroblastoma Clinical Trial 2023: GM-CSF Highlights & Side Effects. Trial Name: NCT03033303 — Phase 2
GM-CSF (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03033303 — Phase 2
~5 spots leftby Jun 2025
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