Accrual goals not met

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