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

• Status: Completed
• Trial end date: 2019-03-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Isotretinoin; Molgramostim; Sargramostim

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.