NCT00990496

A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)

A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Fludarabine	30 mg/m2
DRUG	Cyclophosphamide	600 mg/m2
BIOLOGICAL	CMV Specific Cytotoxic T Lymphocytes (CTL)	CTL Infusion (3 - 5 x 10E6 cells/kg)

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-10-28
• Completion: 2010-10-28
• First posted: 2009-10-06
• Last updated: 2018-05-02