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Monoclonal Antibodies

Immunotherapy for Neuroblastoma

Phase 1
Waitlist Available
Research Sponsored by New Approaches to Neuroblastoma Therapy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have at least one of the following: Recurrent/progressive disease, Refractory disease, Persistent disease
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 of protocol therapy through 30 days following end of protocol therapy
Awards & highlights

Study Summary

This trial will determine how well autologous expanded natural killer cells work with standard dosing of dinutuximab and with or without lenalidomide in treating children with neuroblastoma that has come back or does not respond to treatment.

Who is the study for?
This trial is for children with neuroblastoma that hasn't responded to initial treatments or has come back. They must have a certain type of tumor activity visible on specific scans, be under 30 years old, and have an expected lifespan of at least 12 weeks. Their heart, kidney, liver, and blood functions need to meet set levels. Pregnant or breastfeeding individuals can't join.Check my eligibility
What is being tested?
The study tests the highest dose kids can handle of NK cells (a type of immune cell) combined with dinutuximab (an antibody therapy). It also looks at adding lenalidomide (a cancer drug) to this mix for those who've had no luck with standard treatments for their aggressive neuroblastoma.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system like fever and chills from dinutuximab infusion; low blood counts leading to increased infection risk; tiredness; and skin rashes or other allergic reactions especially when starting lenalidomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disease is either coming back, not responding, or has never fully gone away.
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I have recovered from side effects of my previous cancer treatments.
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I am not taking any other cancer treatments or undergoing radiotherapy while on this trial.
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I have been diagnosed with neuroblastoma confirmed by tests.
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My cancer shows up on specific scans and has been confirmed with a biopsy.
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I am expected to live at least 12 weeks and can do some daily activities on my own.
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I am 30 years old or younger.
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I have a measurable cancer lesion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 of protocol therapy through 30 days following end of protocol therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of protocol therapy through 30 days following end of protocol therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD/RP2D determination
NK cell production feasibility
NK cell production feasibility (lowest dose level)
Secondary outcome measures
Describe Hematological Toxicities
Describe Non-Hematological Toxicities
Overall Response

Trial Design

1Treatment groups
Experimental Treatment
Group I: NK cells with Dinutuximab & LenalidomideExperimental Treatment3 Interventions
Patients in this arm will receive a designated dose of NK cells on Day 5 and 17.5 mg/m2/dose of dinutuximab on Day 1-4. Patients on Dose Level 4 will also receive 25mg/m2/dose of Lenalidomide during Day -6 through 14 of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NK Cells
2020
Completed Phase 2
~40
Dinutuximab
FDA approved
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

New Approaches to Neuroblastoma Therapy ConsortiumLead Sponsor
16 Previous Clinical Trials
1,621 Total Patients Enrolled
16 Trials studying Neuroblastoma
1,621 Patients Enrolled for Neuroblastoma
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,374 Total Patients Enrolled
6 Trials studying Neuroblastoma
171 Patients Enrolled for Neuroblastoma
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,490 Total Patients Enrolled
3 Trials studying Neuroblastoma
117 Patients Enrolled for Neuroblastoma

Frequently Asked Questions

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

What potential hazards could arise when using NK Cells to treat patients?

"With limited clinical data supporting efficacy and safety, NK Cells received a score of 1."

Answered by AI

Who is eligible to join this exploration?

"This trial is targeting 13 people with neuroblastoma aged between 1 month and 30 years old. To be eligible, applicants must have recurrent/progressive or refractory disease that has not responded to frontline therapy; alternatively, persistent but MIBG avid lesions can suffice if biopsied prior to enrollment. FDG-avid sites require a biopsy confirmation of either tumor type as well. These criteria are in addition to any other cellular presence in the bone marrow established by routine morphology tests."

Answered by AI

What disease states does Natural Killer Cell therapy typically target?

"Hemopoietic stem cell transplant patients often receive NK Cells which are also beneficial for treating high risk neuroblastoma, lymphoma, follicular and multiple myelomatous afflictions."

Answered by AI

Is the minimum age requirement for this trial 18 years or older?

"The trial is open to patients aged 1 Month to 30. For comparison, there are 187 trials for minors and 331 for elderly individuals."

Answered by AI

How many venues are facilitating this experiment?

"A total of 12 clinical trial sites are currently accepting participants for this investigation. This includes University of Chicago Comer Children's Hospital in Chicago, UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, and AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus located in Atlanta as well as other locations."

Answered by AI

What are the key aims of this research endeavor?

"This clinical trial primarily seeks to measure the Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D) of the drug by monitoring cell expansion on day 4. Secondary objectives are evaluating Clinical Response per patient, measuring Overall Response in terms of Complete or Partial Remission, and Describing Non-Hematological Toxicities of grade 3 severity or higher on any course."

Answered by AI

What is the max capacity for participation in this clinical research endeavor?

"This medical trial is no longer seeking out new enrollees. It was initially posted on January 14th 2019 and its last edit occured on July 28th 2022. If you are looking for clinical trials with similar qualifications, there are currently 161 investigations involving neuroblastoma patients and 311 studies recruiting participants that have NK cells."

Answered by AI

What prior studies have focused on the application of NK Cells?

"Presently, a total of 311 live trials are assessing the efficacy of NK Cells; with 60 in Phase 3. Most research is based out of Chicago but there are 14215 trial sites across the country."

Answered by AI

Is there capacity for additional participants in this clinical trial?

"Clinicaltrials.gov reports that, while this trial was initially posted on January 14th 2019 and last edited July 28th 2022, it is not presently recruiting participants. However, there are 472 other medical studies actively looking for candidates as we speak."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells
2019. "Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02573896.
All > North Carolina > Revlimid
~1 spots leftby Sep 2024
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