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Monoclonal Antibodies

Hu3F8 + GM-CSF for Neuroblastoma

Phase 1 & 2

Waitlist Available

Led By Brian 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 older than 1 year of age.

Phase II: Patients must have primary or secondary refractory disease in BM, defined as morphologic evidence of NB in BM and/or abnormal 123I-MIBG uptake in osteomedullary sites, OR patients patients in ≥ 2nd CR patients are in ≥2nd CR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if an antibody called Humanized 3F8 (Hu3F8) is safe to use with a drug called granulocyte- macrophage colony stimulating factor (GM-CSF) to treat neuroblastoma.

Who is the study for?

This trial is for patients over 1 year old with high-risk neuroblastoma, which hasn't responded to standard treatments or has come back. They must have a certain number of white blood cells and not be allergic to mouse proteins. Pregnant or breastfeeding women can't join, nor can those with major organ problems (except hearing loss) or active severe infections.Check my eligibility

What is being tested?

The study tests the safety of combining an antibody called Hu3F8 with GM-CSF in treating neuroblastoma. It's looking at how well these two work together against cancer that's hard to treat or has returned after previous treatment.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to the introduction of antibodies from different species (mouse), as well as general side effects like fatigue, fever, and pain at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 1 year.

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My neuroblastoma is not responding to initial treatments or has come back.

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My neuroblastoma is not responding to standard treatments.

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My neuroblastoma is high-risk and fits the specific stage and age criteria.

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I have been diagnosed with neuroblastoma through a biopsy or tests showing cancer spread and high urine catecholamine levels.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

assess the toxicity

maximum tolerated dosage

Secondary outcome measures

assess activity of hu3F8 plus GM-CSF against HR-NB

pharmacokinetics of hu3F8

quantitate the response of marrow NB

Trial Design

2Treatment groups

Experimental Treatment

Group I: expansion phase II single arm trialExperimental Treatment1 Intervention

Group 1 patients have primary refractory disease (no prior relapse but incomplete response to treatment) in BM as documented by histology and/or 123^I-MIBG scan. Group 2 patients are in >2nd CR/VGPR and at high risk for another relapse. Group 3 patients have secondary refractory disease (prior relapse and incomplete response to retrieval therapy) in BM as documented by histology and/or 123^I-MIBG scan. GM-CSF can be omitted if patients have a history of an allergy to GM-CSF or develop an allergic reaction to GM-CSF after initiating therapy while on the protocol.

Group II: Hu3F8 with GM-CSFExperimental Treatment1 Intervention

The phase I single arm trial assesses escalating doses of iv hu3F8 (days 1, 3, 5) in the presence of sc GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. The expansion phase II single arm trial assesses the anti-NB activity of hu3F8+GM-CSF.in 3 groups of patients: Group 1 patients have primary refractory disease (no prior relapse but incomplete response to treatment) in BM as documented by histology and/or 123I-MIBG scan. Group 2 patients are in ≥2nd CR and at high risk for another relapse. Group 3 patients have secondary refractory disease (prior relapse and incomplete response to retrieval therapy) in BM as documented by histology and/or 123I-MIBG scan. Ph II: Groups 1 & 3 pts can continue to get cycles every 1-2 months for up to 24 months from study enrollment or until they receive 5 cycles after a major response (CR or PR) is achieved.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,371 Total Patients Enrolled

12 Trials studying Neuroblastoma

1,006 Patients Enrolled for Neuroblastoma

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,018 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,605 Patients Enrolled for Neuroblastoma

Brian Kushner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

951 Total Patients Enrolled

10 Trials studying Neuroblastoma

951 Patients Enrolled for Neuroblastoma

Media Library

Hu3F8 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01757626 — Phase 1 & 2

Neuroblastoma Research Study Groups: expansion phase II single arm trial, Hu3F8 with GM-CSF

Neuroblastoma Clinical Trial 2023: Hu3F8 Highlights & Side Effects. Trial Name: NCT01757626 — Phase 1 & 2

Hu3F8 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01757626 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have other similar trials been conducted in the past?

"There are currently 7 active Hu3F8 With GM-CSF trials being conducted in 8 cities and 9 countries. The first study was completed in 2011 by Y-mAbs Therapeutics. That particular trial, which had 68 participants, only reached Phase 1 of drug approval. In the last ten years, one more study has been completed."

Answered by AI

How many test subjects are needed for this experiment?

"As of right now, this trial has no open positions. The study was first established on December 1st, 2012 and updated as recently as May 2nd, 2022. If you're looking for other trials to participate in, there are 165 active trials for neuroblastoma and 7 for Hu3F8 With GM-CSF that are currently enrolling patients."

Answered by AI

Are there similar procedures which use Hu3F8 With GM-CSF?

"Currently, there are seven clinical trials underway that are studying the efficacy of Hu3F8 With GM-CSF. Of those ongoing studies, none have reached Phase 3 yet. Most of the research for this treatment is based in New york, New York; however, there are a total of 32 locations running these sorts of study across the United States."

Answered by AI

Are we able to sign people up for this experiment right now?

"This particular clinical trial is not looking for any more participants at the moment, as seen on clinicaltrials.gov. The first posting was on December 1st, 2012 and the most recent edit was done on May 2nd, 2022. Even though this study isn't recruiting right now, there are 172 other medical trials that are actively seeking patients."

Answered by AI

Recent research and studies

OncoImmunologyJournal

Phase I Trial of Anti-gd2 Monoclonal Antibody Hu3f8 Plus GM-CSF: Impact of Body Weight, Immunogenicity and Anti-gd2 Response on Pharmacokinetics and Survival

Cheung, Irene Y., Brian H. Kushner, Shakeel Modak, Ellen M. Basu, Stephen S. Roberts, and Nai-Kong V. Cheung. 2017. “Phase I Trial of Anti-gd2 Monoclonal Antibody Hu3f8 Plus GM-CSF: Impact of Body Weight, Immunogenicity and Anti-gd2 Response on Pharmacokinetics and Survival”. Oncoimmunology. Informa UK Limited. doi:10.1080/2162402x.2017.1358331.

JAMA OncologyJournal

Humanized 3F8 Anti-g<sub>d2</sub>monoclonal Antibody Dosing with Granulocyte-macrophage Colony-stimulating Factor in Patients with Resistant Neuroblastoma

Kushner, Brian H., Irene Y. Cheung, Shakeel Modak, Ellen M. Basu, Stephen S. Roberts, and Nai-Kong Cheung. 2018. “Humanized 3F8 Anti-gd2monoclonal Antibody Dosing with Granulocyte-macrophage Colony-stimulating Factor in Patients with Resistant Neuroblastoma”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2018.4005.

clinicaltrials.govStudy

Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

2012. "Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01757626.

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