32
Participants
Start Date
December 31, 1997
Primary Completion Date
January 31, 2001
Study Completion Date
April 30, 2016
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.
Houston Methodist Hospital, Houston
Texas Children's Hospital, Houston
The Methodist Hospital Research Institute
OTHER
Center for Cell and Gene Therapy, Baylor College of Medicine
OTHER
St. Jude Children's Research Hospital
OTHER
Baylor College of Medicine
OTHER