Clinical trial · Interventional
Monoclonal Antibody 3F8 and GM-CSF in Treating Young Patients With High-Risk, Refractory or Relapsed Neuroblastoma
3F8 Antibody Dose Escalation Plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma: A Phase I Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for neuroblastoma. PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody 3F8 when given together with GM-CSF in treating young patients with high-risk, refractory or relapsed neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody 3F8 | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3F8 and GM-CSF
- description
- One cycle has 5 days of 3F8 treatment. Each day, patients receive GM-CSF subcutaneously \~1.5 hr before the start 3F8 infusion. To limit side-effects, patients receive analgesics, antihistamines, and a small dose (IV, over \~5 minutes) of heat-modified 3F8. Cycles can be repeated after a 2-4 week interval, up to a total of two cycles.
- interventionNames
- Biological: monoclonal antibody 3F8
- Biological: sargramostim
Primary outcomes (2)
- measure
- Maximum tolerated dose of monoclonal antibody 3F8
- timeFrame
- 2 years
- measure
- Anti-neuroblastoma effects of monoclonal antibody 3F8 and sargramostim (GM-CSF)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of NB as defined by international criteria,45 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels. * Patients must have refractory or relapsed high-risk NB (including MYCNamplified stage 3/4/4S and MYCN-nonamplified stage 4 \>18 months old) resistant to standard therapy. * Prior treatment with 3F8 is allowed. * Age \<21 years. * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * Existing major organ dysfunction should be grade 2 or less, with the exception of myelosuppression (neutrophil count \>500/ul and platelet count \>10,000/ul are acceptable), alopecia, hearing loss. Patient cannot be taking antihypertensive medication. * History of allergy to mouse proteins. * Active life-threatening infection. * Human anti-mouse antibody (HAMA) titer \>1000 ELISA units/ml. * Prior treatment with 3F8 is NOT an exclusion criterion. * Inability to comply with protocol requirements. * Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
References
Publications (1)
- RESULTKushner BH, Kramer K, Modak S, Cheung NK. Successful multifold dose escalation of anti-GD2 monoclonal antibody 3F8 in patients with neuroblastoma: a phase I study. J Clin Oncol. 2011 Mar 20;29(9):1168-74. doi: 10.1200/JCO.2010.28.3317. Epub 2011 Feb 22. PMID 21343563