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)

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.

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.

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