New vaccine aims to train immune system to attack childhood cancer
NCT ID NCT00911560
First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This trial tests a vaccine designed to help the immune system recognize and attack neuroblastoma, a type of childhood cancer. The vaccine contains two antigens found on neuroblastoma cells, plus an adjuvant to boost the immune response. Participants also take an oral supplement called β-glucan, which may help white blood cells kill cancer. The study includes children with high-risk neuroblastoma who have completed initial treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bivalent vaccine (GD2L and GD3L antigens linked to KLH) with OPT-821 adjuvant and oral β-glucan
- What this could lead to
- If successful, this vaccine could help the immune system target and kill neuroblastoma cells, potentially improving long-term control of the disease.
- What could go wrong
- This is an early-phase trial (phase I/II) with a small number of participants. The vaccine may not produce a strong enough immune response, or side effects could limit its use.
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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374 people
The number who actually took part.
- Started
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May 2009
- Finished
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Aug 2026
- 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
-
Up to 21 years
- Sex
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Anyone
- Healthy volunteers
-
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 neuroblastoma (NB) as defined by international criteria,\[104\] i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels. * High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System,\[104\] i.e., stage 4 with MYCN amplification (any age) stage 4 \>18 months old. * High-risk NB (as defined above) and in 1) first CR at 6 ≥ months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent remission. Remission is defined as complete (CR) remission, according to the International Neuroblastoma Response Criteria.\[104\] Urine catecholamine levels are no longer taken into consideration when staging. * Absolute lymphocyte count ≥ 500/mcl and absolute neutrophil count ≥ 500/mcl. * Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 3.0) developed by the National Cancer Institute of the USA (CTCAE v3.0) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. * ALT, AST and Alkaline Phosphatase ≤ 2.5 times the upper limit of normal * Prior treatment with other immunotherapy, including antibodies, is allowed * ≥ 3 weeks and no more than 6 months (\<180 days) between completion of systemic therapy and 1st vaccination. * Patients previously enrolled on this trial are eligible for repeat enrollment but will be assigned to treatment as per the control arm (Group 1) and will not be included in the biostatistical analyses. * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * History of allergy to KLH, QS-21, OPT-821, or glucan. * Active life-threatening infection. * Inability to comply with protocol requirements.
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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
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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