N/A
N=69
Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma
Neuroblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02100930 ↗Enrolled (actual)
69
Serious AEs
37.7%
Results posted
Feb 2020
Primary outcome: Primary: Therapeutic Response — 40; 3; 1; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anti-GD2 3F8 Monoclonal Antibody (Biological); GM-CSF (granulocyte-macrophage colony-stimulating factor) (Drug); oral isotretinoin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Response |
40; 3; 1; 6; 19 | — |
| PRIMARY Complete Remission |
40; 3; 1; 6; 19 | — |
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.
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.
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.