← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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