drugset / Trial / NCT00698009

Haploidentical Natural Killer (NK) Cells in Patients With Relapsed or Refractory Neuroblastoma

NCT00698009

Phase 2 Terminated 1 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

Primary: Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2). Secondary: * Quantification of cytokine levels; * Assessment of NK cell immunophenotype and function.

Timeline

Start
2008-06
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject TROCULEUCEL Cell therapy Intravenous
Subject aldesleukin Protein / enzyme biologic 5e+06 unknown Subcutaneous
Subject aldesleukin Protein / enzyme biologic 1e+07 iu Subcutaneous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 12 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous

Indications