26
Participants
Start Date
April 30, 2014
Primary Completion Date
October 31, 2019
Study Completion Date
October 31, 2034
GD2 T cells
"On dose levels 1 and 2 each patient receives one injection of GD2 T cells followed by VZV vaccine injection 42 days later.~Dose Level 1: 1x10\^6 cells/m\^2~Dose Level 2: 1x10\^7 cells/m\^2~The next dose levels to be studied following Dose level 2 are Dose levels 7 and 8 where subjects will receive the VZV vaccine followed by a single infusion of iC9-GD2-CAR-VZV-CTLs within 48 hours after VZV vaccine:~Dose Level 7: 1 x 10\^7 cells/m2~Dose Level 8: 1 x 10\^8 cells/m\^2~Dose levels 9-11 will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to administration of the T cells.~Dose Level 9: 1 x 10\^8 cells/m\^2~Dose Level 10: 5 x 10\^8 cells/m\^2~Dose Level 11: 1 x 10\^9 cells/m\^2~The previously planned dose levels 3-6 will not be studied."
VZV vaccine
Subjects will receive a VZV vaccine with CTL infusion within 48 hours after the vaccine.
Fludarabine
Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m\^2/day followed by Fludarabine 30 mg/m\^2/day. Infusions should be given following hospital/pharmacy recommendations however at a minimum the cyclophosphamide should be infused over 1 hour and the fludarabine should be infused over 30 minutes. Mesna, IV hydration, and anti-emetics will be provided following local institutional guidelines. T cell infusion will take place the day after completion of chemotherapy. Zostavax will be administered two weeks after infusion of T cells.
Cyclophosphamide
Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m\^2/day followed by Fludarabine 30 mg/m\^2/day. Infusions should be given following hospital/pharmacy recommendations however at a minimum the cyclophosphamide should be infused over 1 hour and the fludarabine should be infused over 30 minutes. Mesna, IV hydration, and anti-emetics will be provided following local institutional guidelines. T cell infusion will take place the day after completion of chemotherapy. Zostavax will be administered two weeks after infusion of T cells.
Houston Methodist Hospital, Houston
Texas Children's Hospital, Houston
National Cancer Institute (NCI)
NIH
Center for Cell and Gene Therapy, Baylor College of Medicine
OTHER
The Methodist Hospital Research Institute
OTHER
Baylor College of Medicine
OTHER