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)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990496

Enrollment

Registered

2009-10-06

Start date

2009-09-30

Completion date

2010-10-28

Last updated

2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma multiforme, GBM, Cytomegalovirus, CMV, Cytotoxic T lymphocyte, CTL

Brief 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.

Detailed description

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.

Interventions

DRUGFludarabine

30 mg/m2

DRUGCyclophosphamide

600 mg/m2

BIOLOGICALCMV Specific Cytotoxic T Lymphocytes (CTL)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.	2 years

Secondary

Measure	Time frame
To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.	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.	2 years
To determine safety of allogeneic CTL infusions in this patient population.	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026