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Chemotherapy

Hu3F8 + NK Cells for High-Risk Neuroblastoma

Phase 1

Waitlist Available

Led By Shakeel Modak, 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

High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System, i.e., stage 4 with (any age) or without (>365 days of age) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S.

Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy.

Must not have

Women who are pregnant or breast-feeding

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 it's safe to give a chemotherapy drug, natural killer cells, and an antibody to people with neuroblastoma. It's funded by the FDA.

Who is the study for?

This trial is for children and adults with high-risk neuroblastoma who haven't responded well to standard treatments. Participants need a compatible NK cell donor, must have evidence of persistent or progressing disease, and cannot be pregnant or breastfeeding. They should not have severe organ dysfunction or life-threatening infections.

What is being tested?

The study tests the safety and feasibility of combining cyclophosphamide (chemotherapy), natural killer (NK) cells, and Hu3F8 antibody as a treatment for neuroblastoma. It's an early-phase trial to see how patients tolerate this approach before considering further studies.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation, allergic responses due to mouse proteins in Hu3F8, blood cell count changes from chemotherapy, fatigue, nausea, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My neuroblastoma is considered high-risk based on its stage and MYCN gene status.

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My cancer can be measured or seen on scans after my last treatment.

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I have been diagnosed with neuroblastoma based on tissue tests or bone marrow and urine tests.

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My cancer has not fully responded or has worsened despite treatment.

Exclusion Criteria

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

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I am not pregnant or breast-feeding.

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

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My cancer is responding very well to treatment.

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

The number patient responses observed at each dose level

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: Humanized Anti-GD2 Antibody Hu3F8Experimental Treatment4 Interventions

This is a phase I study to assess the safety and feasibility of combining HLA-mismatched (KIR ligand incompatible) NK cells with hu3F8 in high-risk NB patients. Following chemotherapy, patients will be treated in sequential groups with a minimum of 3 patients/ dose of NK cells. Three dose levels of NK cells, starting at dose level 1, will be evaluated in this treatment protocol. The goal dose for each dose level is the high boundary (e.g. 9.9x10\^6/kg in level 1; 14.9x10\^6/kg in level 2, etc), but a range is provided to allow for cases where the goal dose cannot be achieved.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cyclophosphamide

1994

Completed Phase 3

~8140

NK cells

2008

Completed Phase 2

~100