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Chemotherapy

Hu3F8 + NK Cells for High-Risk Neuroblastoma

Q: What therapeutic purpose do NK cells typically serve?

<p>NK cells are widely used to combat <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">Multiple sclerosis</a>, and also have applications in treating leukaemia, myelocytic, acute forms of retinoblastoma, and histiocytic lymphomas.</p>

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

The number patient responses observed at each dose level

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

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,719 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,706 Patients Enrolled for Neuroblastoma

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,472 Total Patients Enrolled

12 Trials studying Neuroblastoma

1,107 Patients Enrolled for Neuroblastoma

Shakeel Modak, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

9 Previous Clinical Trials

299 Total Patients Enrolled

7 Trials studying Neuroblastoma

242 Patients Enrolled for Neuroblastoma

Media Library

cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02650648 — Phase 1

Neuroblastoma Research Study Groups: Humanized Anti-GD2 Antibody Hu3F8

Neuroblastoma Clinical Trial 2023: cyclophosphamide Highlights & Side Effects. Trial Name: NCT02650648 — Phase 1

cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02650648 — Phase 1

Frequently Asked Questions

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

Are there any research studies that have been conducted in regard to natural killer cells?

"Currently, there are 843 live medical trials involving NK cells with 154 of them being in the final phase. Although Philadelphia has a large number of studies related to this topic, 27889 sites across the world have research activities concentrating on NK cells."

Answered by AI

What therapeutic purpose do NK cells typically serve?

"NK cells are widely used to combat Multiple sclerosis, and also have applications in treating leukaemia, myelocytic, acute forms of retinoblastoma, and histiocytic lymphomas."

Answered by AI

Is recruitment still ongoing for the clinical trial?

"This trial is no longer enrolling participants; it was first published on January 1st 2016, and most recently updated on February 14th 2022. Those seeking a similar study should know that there are currently 165 trials actively recruiting patients with neuroblastoma, as well as 843 studies for NK cells which are accepting enrolments."

Answered by AI

What hazards might be associated with elevated NK cell counts?

"Given the early stage of development, our experts at Power assigned a score of 1 to NK cells due to minimal evidence for efficacy and safety."

Answered by AI

How many individuals have been enlisted to participate in this medical trial?

"As of 2/14/2022, this medical research is not accepting applications. Originally posted on 1/1/2016, the study has unable to find enough participants. However, if you are seeking an alternative trial that works with neuroblastoma patients there are currently 165 prospective studies and 843 for natural killer cell related trials recruiting volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

2016. "Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02650648.

All > Neuroblastoma