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