A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    264
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 4 April 2023
See if I qualify
platelet count
renal function
cancer
bone marrow procedure
colony stimulating factor
neutrophil count
EGFR
high-risk neuroblastoma
mycn protein
Accepts healthy volunteers

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.

Details
Condition Neuroblastoma
Treatment GM-CSF, β-glucan, OPT-821, OPT-821
Clinical Study IdentifierNCT04936529
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 April 2023

Eligibility

 Yes No Not Sure

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
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
eGFR >60 mL/min/1.73 m^2
Hepatic Function
Prior treatment with other immunotherapy, including mAbs or vaccine, is allowed but must be completed ≥ 21 days before the 1st vaccination
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
A negative pregnancy test is required for patients w ith child-bearing capability
Serum bilirubin ≤ 3.0 × ULN
Aspartate transaminase (AST) ≤ 5.0 × ULN
Alanine aminotransferase (ALT) ≤ 5.0 × ULN
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 with history of allergy to GM-CSF or who are unable to obtain GM-CSF because
of insurance issues are eligible but will be assigned to Group 3 (no GM-CSF
exploratory arm)
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
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
Inability to comply with protocol requirements
Active life-threatening infection requiring systemic therapy
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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