Hu3F8 + GM-CSF + Isotretinoin for Neuroblastoma

Recruiting in Palo Alto (17 mi)

Brian H. Kushner, MD - MSK Pediatric ...

Overseen byBrian Kushner, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is in its first complete or very good partial response.

My neuroblastoma diagnosis is confirmed by specific tests and high urine catecholamine levels.

My neuroblastoma is high-risk, either due to MYCN amplification or being over 18 months with stage 4.

+1 more

Exclusion Criteria

Inability to comply with protocol requirements

I do not have severe organ problems, except possible hearing loss or blood issues.

I do not have a severe infection that is threatening my life.

Participant Groups

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.

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.

GM-CSF is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Leukine for: