N/A Completed N=69 Treatment

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

neuroblastoma

Source: ClinicalTrials.gov NCT02100930 ↗

Enrolled (actual)

Serious AEs

37.7%

Results posted

Feb 2020

Primary outcomePrimary: Therapeutic Response — 40; 3; 1; 6 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Therapeutic Response	40; 3; 1; 6; 19	—
PRIMARY Complete Remission	40; 3; 1; 6; 19	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02100930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.