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

Phase 1

Terminated

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)

• Registration Number: NCT00990496
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Primary Completion: 2010-10-28
• Study Completion: 2010-10-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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%.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GBM Treatment	CMV Specific Cytotoxic T Lymphocytes (CTL)	-
GBM Treatment	Fludarabine	-
GBM Treatment	Cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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