Antibody-Chemo cocktail targets tough childhood cancer
NCT ID NCT03189706
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests whether adding an experimental antibody called Hu3F8 to a standard chemotherapy regimen (irinotecan and temozolomide) plus a immune-boosting drug (GM-CSF) is safe and effective for children with high-risk neuroblastoma. The trial enrolls patients whose neuroblastoma is defined as high-risk based on stage and genetic features. Researchers will monitor side effects and measure how well the tumor responds over four cycles of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hu3F8 (antibody), irinotecan, temozolomide, and GM-CSF
- What this could lead to
- If successful, this combination could offer a new treatment option for children with high-risk neuroblastoma, potentially improving response rates.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The combination may cause significant side effects, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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48 people
The number who actually took part.
- Started
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Jun 2017
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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.
Inclusion Criteria: * Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels * High-risk NB as defined as any of the following: * Stage 4 with MYCN amplification (any age) * Stage 4 without MYCN amplification (\>1.5 years of age) * Stage 3 with MYCN amplification (unresectable; any age) * Stage 4S with MYCN amplification (any age) * Patients fulfill one of the following criteria: 1. Have evidence of soft tissue disease OR 2. If they only have osteomedullary disease at protocol enrollment, they should have: * Had previously received Hu3F8+GMCSF therapy AND have had less than a complete response to it OR * Had progressed progressive disease after their most recent anti-neuroblastoma therapeutic regimen * 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. * Prior treatment with murine and hu3F8 is allowed. * Prior treatment with irinotecan or temozolomide is permitted. * Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody positivity is allowed. * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * Patients with CR/VGPR disease * Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 except for hearing loss, alopecia, anorexia, nausea, and hypomagnesemia from TPN, which may be grade 3 * ANC \< 500/uL * Platelet count \<30K/uL * History of allergy to mouse proteins * Active life-threatening infection * Inability to comply with protocol requirements * Women who are pregnant or breast-feeding
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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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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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