drugset / Trial / NCT00048386
Neuroblastoma Vaccine for Treatment of High-Risk Neuroblastoma After Chemotherapy
Phase 1
Completed
13 enrolled
Malcolm Brenner
Baylor College of Medicine · collabCenter for Cell and Gene Therapy, Baylor College of Medicine · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in first or subsequent partial response or better, or with microscopic residual bone marrow disease, who demonstrate an immunological anti-tumor response at any time during, and for up to 12 months from initiation of, treatment with subcutaneous injections of autologous neuroblastoma cells, genetically modified by adenoviral vectors to secrete interleukin-2 (IL-2) (autologous neuroblastoma vaccine) SECONDARY OBJECTIVES 1. To determine the toxicity of the autologous neuroblastoma vaccine given according to this schedule 2. To obtain preliminary data on the effect of vaccine administration on progression-free survival from high-risk neuroblastoma
Timeline
- Start
- 1999-11
- Primary completion
- 2004-12
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous neuroblastoma vaccine | Vaccine | 3e+07 cells | Subcutaneous |