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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

Must not have

Positive human anti-hu3F8 antibody (HAHA) titer

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 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for HAHA antibodies.

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I do not have a life-threatening infection.

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

assess the toxicity

maximum tolerated dosage

Secondary study objectives

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

pharmacokinetics of hu3F8

quantitate the response of marrow NB

Awards & Highlights

No Placebo-Only Group

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

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 / 7Eligibility criteria met