iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2034

Conditions
OsteosarcomaNeuroblastoma
Interventions
GENETIC

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."

BIOLOGICAL

VZV vaccine

Subjects will receive a VZV vaccine with CTL infusion within 48 hours after the vaccine.

DRUG

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.

DRUG

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.

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

lead

Baylor College of Medicine

OTHER