Phase I Study of Chemokine and Cytokine Gene Modified Allogeneic Neuroblastoma Cells For Treatment of Relapsed/Refractory Neuroblastoma Using a Retroviral Vector
Secondary objectives for this protocol included the following:
- To determine whether major histocompatibility complex (MHC) restricted or unrestricted
antitumor immune responses are induced by injection of modified allogeneic neuroblasts
and the cell doses required to produce these effects.
- To obtain preliminary data on the antitumor effects of this treatment regimen.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• To determine the safety of up to eight subcutaneous injections of allogeneic neuroblastoma cells that have been genetically modified by retroviral vectors to secrete lymphotactin and Interleukin-2
Gregory A Hale, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
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