A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.
Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)|
- To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine safety of allogeneic CTL infusions in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion.