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Monoclonal Antibodies

Combination Therapy for Neuroblastoma

Phase 2
Waitlist Available
Led By Wayne L. Furman, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed, advanced stage, high-risk neuroblastoma meeting specific criteria including age, INSS stage, MYCN amplification, and biologic features
Participants <19 years of age (eligible until 19th birthday)
Must not have
Children with specific INSS 4 disease criteria
Any evidence of severe or uncontrolled systemic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new monoclonal antibody (mAb) to see if it is effective in treating neuroblastoma, a cancer that commonly affects children. The mAb targets a protein that is found on the surface of neuroblastoma cells.

Who is the study for?
This trial is for children under 19 with high-risk neuroblastoma, a type of cancer. They must have specific stages of the disease and certain genetic features like MYCN amplification. Kids who've had no prior treatment except in emergencies can join. Parents may donate cells if they're over 18. Children with severe diseases or girls who are pregnant can't participate.
What is being tested?
The trial tests a new antibody called hu14.18K322A combined with chemotherapy to see if it helps kids with neuroblastoma enter remission (disease improvement). It also looks at whether this treatment extends the time patients live without their disease getting worse and how well radiation therapy works on abdominal tumors.
What are the potential side effects?
Possible side effects include reactions to the monoclonal antibody such as inflammation, allergic responses, and discomfort at infusion sites; chemotherapy-related issues like nausea, hair loss, blood cell count changes; and risks from stem cell transplant procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with advanced, high-risk neuroblastoma.
Select...
I am under 19 years old.
Select...
My child's cancer progressed to stage 4 without chemotherapy after initial diagnosis.
Select...
My cancer diagnosis was confirmed with specific tests for neuroblastoma.
Select...
I have not had any treatment before, except in an emergency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child has a specific stage 4 neuroblastoma.
Select...
I do not have any severe or uncontrolled illnesses.
Select...
I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Event-free Survival (EFS)
Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]
Secondary study objectives
Dose Limiting Toxicity (DLT)
Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation
Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy
+1 more

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: TreatmentExperimental Treatment21 Interventions
Participants receive IV hu14.18K322A with each course of chemotherapy (cyclophosphamide, topotecan, cyclophosphamide, doxorubicin, vincristine, cisplatin, and etoposide). Mesna will be given prior to and after cyclophosphamide infusion. Peripheral blood stem cell harvest (PBSC) and surgical resection of primary tumor will be performed, if feasible. Intensification therapy includes busulfan, melphalan, and levetiracetam with peripheral blood stem cell transplantation. A course of hu14.18K322A with natural killer cell infusion will be given to consenting participants. Radiation therapy will follow PBSC transplant with the exception of any patient requiring emergent radiotherapy. MRD treatment includes hu14.18K322A, G-CSF, GM-CSF, interleukin-2 and isotretinoin. Cells for infusion are prepared using the CliniMACS System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
busulfan
1999
Completed Phase 3
~3630
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330
natural killer cell infusion
2013
Completed Phase 2
~80
radiation therapy
1994
Completed Phase 3
~13390
GM-CSF
2011
Completed Phase 4
~1290
vincristine
2005
Completed Phase 4
~3840
surgical resection
2016
Completed Phase 3
~290
mesna
1992
Completed Phase 3
~1420
interleukin-2
2009
Completed Phase 3
~450
melphalan
1994
Completed Phase 3
~3530
doxorubicin
2005
Completed Phase 3
~9130
Isotretinoin
2019
Completed Phase 4
~3520
etoposide
1994
Completed Phase 3
~9300
levetiracetam
2008
Completed Phase 4
~920
cisplatin
1997
Completed Phase 3
~3290
G-CSF
2014
Completed Phase 4
~1610
CliniMACS
2005
Completed Phase 3
~770
cyclophosphamide
1994
Completed Phase 3
~8140
topotecan
2009
Completed Phase 3
~870
hu14.18K322A
2014
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Cookies for Kids' CancerOTHER
6 Previous Clinical Trials
205 Total Patients Enrolled
1 Trials studying Neuroblastoma
65 Patients Enrolled for Neuroblastoma
CURE Childhood Cancer, Inc.OTHER
4 Previous Clinical Trials
76 Total Patients Enrolled
2 Trials studying Neuroblastoma
57 Patients Enrolled for Neuroblastoma
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,328 Total Patients Enrolled
24 Trials studying Neuroblastoma
5,843 Patients Enrolled for Neuroblastoma
Wayne L. Furman, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
2 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Neuroblastoma
64 Patients Enrolled for Neuroblastoma
Sara M. Federico, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
1,067 Total Patients Enrolled

Media Library

hu14.18K322A (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01857934 — Phase 2
Neuroblastoma Research Study Groups: Treatment
Neuroblastoma Clinical Trial 2023: hu14.18K322A Highlights & Side Effects. Trial Name: NCT01857934 — Phase 2
hu14.18K322A (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01857934 — Phase 2
~12 spots leftby Dec 2025
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