Vaccine combined with β-glucan and GM-CSF for treating high-risk neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a bivalent vaccine in combination with β-glucan and GM-CSF for patients with high-risk neuroblastoma who are in complete remission. The approach aims to enhance the immune system's ability to target and eliminate cancer cells through a multi-faceted treatment strategy. Participants will receive the combination therapy to assess its safety and efficacy in improving outcomes for this challenging condition.

Why it matters

Who can join: the full rules

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. If there is a positive site of disease that is poorly visualized on a scan, it can be per PI discretion to repeat the scan or proceed with enrollment without a scan.
* 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

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Brian Kushner, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Brian Kushner, MD
• Email: kushnerb@mskcc.org
• Phone: 1-833-675-5437

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.