A Safety/Feasibility Trial of the Addition of the Humanized Anti-GD2 Antibody (hu14.18K322A) With and Without Natural Killer Cells to Chemotherapy in Children and Adolescents With Recurrent/Refractory Neuroblastoma
Eligible participants will receive chemotherapy combined with Hu14.18K322A antibody daily
for four consecutive days. Those participants who go on to receive the second course of
chemotherapy with Hu14.18K322A will receive an infusion of allogeneic NK cells after the 4th
dose of Hu14.18K322A antibody. A maximum of six courses will be given.
Primary Objective:
- To observe and describe the toxicities associated with humanized anti-GD2 antibody
(hu14.18K322A) with and without allogeneic NK cells when given with repeated cycles of
chemotherapy to children with refractory/relapsed neuroblastoma.
Secondary Objective:
- To describe response, time to progression, event-free and overall survival.
- To evaluate the feasibility of administering NK cells from a suitable donor after
completion of the last dose of hu14.18K322A in three repeated cycles of chemotherapy
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients experiencing unacceptable toxicity associated with humanized anti-GD2 antibody/chemotherapy (course 1) and anti-GD2 antibody/chemotherapy/NK cells (course 2).
Unacceptable toxicities are defined as: 1) any grade 4 toxicity that does not return to baseline by day 35, 2) any toxicity requiring the use of pressors, including grade 4 acute capillary leak syndrome or grade 3 or 4 hypotension, 3) any toxicity requiring ventilation support, including grade 4 respiratory toxicity, 4) grade 4 neutropenia or thrombocytopenia lasting > 35 days (only during course 2), and 5) death from toxicity.
First two courses of treatment (42 days)
Yes
Wayne L. Furman, MD
Principal Investigator
St. Jude Children's Research Hospital
United States: Institutional Review Board
GD2NK
NCT01576692
April 2012
April 2018
Name | Location |
---|---|
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |