← Back to Search

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1350

Isotretinoin

2019

Completed Phase 4

~3520