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Neuroblastoma | Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

Neuroblastoma research study

What is the primary objective of this study?

The purpose of this study is to be able to supply an experimental combination of drugs called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may benefit from treatment.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of NB as defined by international criteria,62 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels. - High-risk NB, as defined by risk-related treatment guidelines and the International NB Staging System, i.e., stage 4 with (any age) or without (>18 months) MYCNamplification, 63 or MYCN-amplified NB other than stage 1.64,65 - Patients are in CR/VGPR or have primary refractory NB in BM - i.e., NB resistant to standard therapy, as evidenced by persistence of NB in BM by histology or MIBG scan, but all other findings in scans show VGPR. - Children and adults are eligible. - Signed informed consent indicating awareness of the scheduling and side effects, as well as testing requirements, of this program. Exclusion Criteria: - Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity > or = to grade 3, except for grade 3 hematologic toxicity. - Progressive disease (PD) - History of allergy to mouse proteins. - Active life-threatening infection. - Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml. - Pregnant women - Inability to comply with protocol requirements.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Neuroblastoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Anti-GD2 3F8 Monoclonal Antibody

Drug:GM-CSF (granulocyte-macrophage colony-stimulating factor)

Drug:oral isotretinoin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

NeuroblastomaThis is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.

Study Status

Recruiting

Start Date: March 2014

Completed Date: March 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: relapse-free survival

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Brian Kushner, MD

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02100930

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