NCT04936529 A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
| NCT ID | NCT04936529 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 286 participants |
| Start Date | 2021-08-02 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 286 participants in total. It began in 2021-08-02 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) as an effective treatment for people with high-risk neuroblastoma that is in complete remission. The combination may be effective because the different parts of the treatment work to strengthen the immune system's response against cancer cells in different ways.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels or positivity in MIBG scan * 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. For those patients with a positive MIBG scan, the negative FDG-PET scan can be per PI discretion to repeat within the 45 day window period prior to enrollment. * 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: * Patients w ith significant (grade \>4) hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) * 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
Contact & Investigator
Brian Kushner, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04936529 clinical trial?
This trial is open to participants of all sexes, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04936529 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04936529 currently recruiting?
Yes, NCT04936529 is actively recruiting participants. Contact the research team at kushnerb@mskcc.org for enrollment information.
Where is the NCT04936529 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04936529 clinical trial?
NCT04936529 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Brian Kushner, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 286 participants.