A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma (NCT04936529) | Clinical Trial Compass
RecruitingPhase 2
A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
United States286 participantsStarted 2021-08-02
Plain-language 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.
Who can participate
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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.
* 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
* Aspar…