Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma: Assessment of Tolerability and In Vivo Expansion γδ T-Cells
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety and toxicity of zoledronic acid and aldesleukin
The NCI Common Terminology Criteria for AEs will be used for reporting & identification of dose limiting toxicities. DLTs will include any grade 3 non-hematologic toxicity not included here: Gr 3 nausea & vomiting & diarrhea, Gr 3 fever, Gr 3 skin toxicity that remains stable & tolerable, or improves with treatment within 24 hrs, Gr 3 neurotoxicity with subjective findings, Gr 4 hematologic toxicity, which improves to at least Gr 2 or baseline pre-therapy values within one week of completing IL2 infusion, Gr 3 performance that returns to 50 or higher before the start of the next therapy cycle.
1.5 years
Yes
Joseph Pressey, MD
Principal Investigator
The University of Alabama at Birmingham
United States: Institutional Review Board
UAB 1051
NCT01404702
August 2011
September 2014
Name | Location |
---|---|
University of Alabama at Birmingham-Children's of Alabama | Birmingham, Alabama 35233 |