Overview

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

Status:
Terminated
Trial end date:
2010-10-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Milton S. Hershey Medical Center
Penn State University
Treatments:
Cyclophosphamide
Fludarabine
Criteria
Inclusion Criteria:

FOR SCREENING

- Patients must have a histopathologic diagnosis of GBM.

- Patients from 5 to 65 years of age with GBM.

FOR TREATMENT

- GBM has progressed following primary therapy.

- Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).

- Subjects must have pulse oximetry > or = 94 % on no supplemental oxygen.

- Creatinine clearance must be > 50 cc/min as estimated by patient's serum creatinine,
weight, and age.

- Bilirubin must be < 2.0 mg/dl and SGOT/SGPT < 2.5 X normal.

- ECOG performance status must be < or = 2, and for patients <16 years of age, Lansky
performance status must be > or = 70%.

Exclusion Criteria:

- Pregnant females

- Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or
neurologic dysfunction are not expected to survive one month following the T cell
infusion