drugset / Trial / NCT00450307
Monoclonal Antibody 3F8 and GM-CSF in Treating Young Patients With High-Risk, Refractory or Relapsed Neuroblastoma
Phase 1
Completed
32 enrolled
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2005-06
- Primary completion
- 2013-04
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3F8 | Monoclonal antibody | 20 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 40 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 60 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 80 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 100 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 120 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 140 mg/m2 | Intravenous |
| Subject | 3F8 | Monoclonal antibody | 160 mg/m2 | Intravenous |
| Background | sargramostim | Protein / enzyme biologic | — | Subcutaneous |