A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
NCT ID: NCT04936529
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
286 participants
INTERVENTIONAL
2021-08-02
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Group 1
Group 1 participants receive oral β-glucan (40 mg/kg/day x 14 days) starting week 1. This schedule includes annual booster vaccinations, with β-glucan, administered at weeks 8, 20, 32, 52, 78, 104, and 156 (vaccinations #1 \& #4-10). Participants will not receive GM-CSF.
β-glucan
Group 1 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). This schedule includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at months 36 (3 years), 48 (4 years), and 60 (5 years).
Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14).
Group 3 participants will be treated as in Group 1.
OPT-821
Vaccine injections must occur a minimum of 6 days apart. After the first four vaccine injections, vaccines can be administered up to two weeks earlier or later than indicated without representing a protocol violation.
Group 2
Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1. Participants also receive GM-CSF (250 mcg/m2/day) x3 days with vaccinations #1-#3; x7 days with vaccinations #4-#9; and x5 days with vaccination #10. The treatment includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at weeks 8, 20, 32, 52, 78, 104, and 156 (vaccinations #1 \& #4-10)
β-glucan
Group 1 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). This schedule includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at months 36 (3 years), 48 (4 years), and 60 (5 years).
Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14).
Group 3 participants will be treated as in Group 1.
GM-CSF
Group 1 participants will not receive GM-CSF.
Group 2 participants will receive GM-CSF (250 mcg/m2/day) x3 days with vaccinations #1-#3; x7 days with vaccinations #4-#11; and x5 days with vaccinations #12-#14.
Group 3 participants will be treated as in Group 1.
OPT-821
Vaccine injections must occur a minimum of 6 days apart. After the first four vaccine injections, vaccines can be administered up to two weeks earlier or later than indicated without representing a protocol violation.
Group 3
Group 3 will include participants who cannot be randomized (e.g., due to allergy to GMCSF). It will also include participants previously treated with this vaccine and oral β-glucan on the predecessor MSK protocol IRB# 05-075 or on this protocol (participants can therefore be enrolled more than one time on this protocol). These participants will be treated as in Group 1. Participants who are registered to Group 3 and have been previously treated with vaccine (in this protocol or MSK predecessor 05-075) will not receive vaccines 4 and 6. These patients will receive a total of 8 injections. The analyses in this group will be exploratory.
β-glucan
Group 1 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). This schedule includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at months 36 (3 years), 48 (4 years), and 60 (5 years).
Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14).
Group 3 participants will be treated as in Group 1.
OPT-821
Vaccine injections must occur a minimum of 6 days apart. After the first four vaccine injections, vaccines can be administered up to two weeks earlier or later than indicated without representing a protocol violation.
Interventions
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β-glucan
Group 1 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). This schedule includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at months 36 (3 years), 48 (4 years), and 60 (5 years).
Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with \~2 weeks on, \~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14).
Group 3 participants will be treated as in Group 1.
GM-CSF
Group 1 participants will not receive GM-CSF.
Group 2 participants will receive GM-CSF (250 mcg/m2/day) x3 days with vaccinations #1-#3; x7 days with vaccinations #4-#11; and x5 days with vaccinations #12-#14.
Group 3 participants will be treated as in Group 1.
OPT-821
Vaccine injections must occur a minimum of 6 days apart. After the first four vaccine injections, vaccines can be administered up to two weeks earlier or later than indicated without representing a protocol violation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HR-NB as defined by risk-related treatment guidelines and international criteria,i.e., metastatic/non-localized disease with MYCN amplification (any age), MYCN-non-amplified metastatic disease \>18 months old, MYCNamplified localized disease (any age), or disease resistant to standard chemotherapy.
* HR-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 CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria.Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible.
* Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam.
* Hematologic Function
* Absolute neutrophil count (ANC) ≥ 500/mcl
* Absolute lymphocyte count ≥ 500/mcl
* Hemaglobin (Hgb) ≥ 8 g/dL
* Platelet count ≥ 50,000 mm\^3
* Renal Function o Serum creatinine ≤ 3.0 x ULN
or
* eGFR \>60 mL/min/1.73 m\^2
\- Hepatic Function
* Serum bilirubin ≤ 3.0 × ULN
* Aspartate transaminase (AST) ≤ 5.0 × ULN
* Alanine aminotransferase (ALT) ≤ 5.0 × ULN
* Prior treatment with other immunotherapy, including mAbs or vaccine, is allowed but must be completed ≥ 21 days before the 1st vaccination.
Note: Prior treatment with an investigational therapy must be completed ≥ 28 days before the 1st vaccination.
* ≥ 21 and ≤ 180 days between completion of systemic therapy and 1st vaccination.
* Patients have recovered from any toxicities grade 3 or higher caused by prior therapies.
* Patients previously enrolled on this trial are eligible for repeat enrollment if they did not complete all vaccine injections during the first time on protocol but they will be assigned to Group 3 and will not be included in the primary biostatistical analyses.
* A negative pregnancy test is required for patients w ith child-bearing capability.
* 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 requiring systemic therapy.
* Inability to comply with protocol requirements.
* Patients with history of allergy to GM-CSF or who are unable to obtain GM-CSF because of insurance issues are ineligible
ALL
Yes
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian Kushner, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Fiorella Iglesias Cardenas, MD, MS
Role: CONTACT
Facility Contacts
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Brian Kushner, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-206
Identifier Type: -
Identifier Source: org_study_id
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