Allogeneic Neuroblastoma Cells for Relapsed/ Refractory Neuroblastoma, CYCHEALL

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 31, 1997

Primary Completion Date

January 31, 2001

Study Completion Date

April 30, 2016

Conditions
Neuroblastoma
Interventions
BIOLOGICAL

Injection of allogeneic neuroblastoma cells

Patients will receive a fixed dose of IL-2 gene modified tumor cells (10\^7/kg, 10\^8 max) already shown to be safe from a previous protocol, and an escalating dose of Lptn transduced tumor cells, beginning at 10\^4/kg and rising to 10\^7/kg (10\^8 max). Patients will be assigned to an appropriate dose level for injection # 1. Injection #2 will contain 10 times more Lptn transduced cells than injection #1, until the max dose (10\^8) has been reached in the first injection. The dose of injections 3 through 8 will be the same as the dose of injection #2. Initial injection volumes will be \<1ml and should be injected in a single site. Only if these first patients show no undue local toxicity (including tumor cell growth) will multiple injection sites be used for subsequent high cell-dose studies.

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

St. Jude Children's Research Hospital

OTHER

lead

Baylor College of Medicine

OTHER

NCT01713439 - Allogeneic Neuroblastoma Cells for Relapsed/ Refractory Neuroblastoma, CYCHEALL | Biotech Hunter | Biotech Hunter