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New treatment option for Neuroblastoma
Official title A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
ClinicalTrials.gov ID: NCT04936529
What this study is testing
What is GM-CSF?
GM-CSF is an investigational medicine, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high...
- HR-NB as defined by risk-related treatment guidelines and international criteria,i.e., metastatic/non-localized disease with MYCN amplification (any...
- 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...
- Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA...
- Hematologic Function
You likely can't join if
- Patients w ith significant (grade \>4) hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- ≥ 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.