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

Phase 1TerminatedNCT00990496

Milton S. Hershey Medical Center25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme

Interventions

FludarabineDRUG

30 mg/m2

CyclophosphamideDRUG

600 mg/m2

CMV Specific Cytotoxic T Lymphocytes (CTL)BIOLOGICAL

CTL Infusion (3 - 5 x 10E6 cells/kg)

Eligibility

Sex: ALLMin age: 5 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.

Time frame: 2 years

Secondary Outcomes

To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.

Time frame: 2 years

To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.

Time frame: 2 years

To determine safety of allogeneic CTL infusions in this patient population.

Time frame: 2 years

Data from ClinicalTrials.gov

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