New antibody combo shows promise against tough childhood cancer
NCT ID NCT01857934
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new antibody (hu14.18K322A) added to standard chemotherapy for 153 children with high-risk neuroblastoma, a serious nerve tissue cancer. The goal was to see if the combination improves tumor shrinkage and delays the cancer from coming back. While the treatment aims to control the disease, children still need ongoing monitoring and additional therapies after the study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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153 people
The number who actually took part.
- Started
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Jul 2013
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
PARTICIPANT Inclusion Criteria: * Participants \<19 years of age (eligible until 19th birthday). * Newly diagnosed, advanced stage, high-risk neuroblastoma defined as one of the following: * Children \< 1 year with International Neuroblastoma Staging System (INSS) stage 2a, 2b, 3, 4 or 4S disease AND MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal). * INSS 2a or 2b disease AND MYCN amplification, regardless of age or additional biologic features * INSS stage 3 AND: 1. MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal, regardless of age or additional biologic features 2. Age \> 18 months (\> 547 days) with unfavorable pathology, regardless of MYCN status * INSS stage 4 and: 1. MYCN amplification, regardless of age or additional biologic features 2. Age \> 18 months (\> 547 days) regardless of biologic features 3. Age 12 - 18 months (365 - 547 days) with any of the following three unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index =1) or any biologic feature that is indeterminant/unknown * Children at least 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy. * Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines. * Adequate renal and hepatic function (serum creatinine \<3 x upper limit of normal for age, AST\< 3 x upper limit of normal). * No prior therapy, unless an emergency situation requires local tumor treatment (discuss with principal investigator). * Written, informed consent according to institutional guidelines. PARTICIPANT Exclusion Criteria: * Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). * Pregnant or breast feeding (female of child-bearing potential). * Children with INSS 4 disease, age \<18 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index \>1). DONOR Inclusion Criteria: * Potential donor is a biologic parent * Potential donor is at least 18 years of age.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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