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

NCT ID: NCT00990496

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-10-28

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GBM Treatment

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

30 mg/m2

Cyclophosphamide

Intervention Type: DRUG

600 mg/m2

CMV Specific Cytotoxic T Lymphocytes (CTL)

Intervention Type: BIOLOGICAL

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

Interventions

Fludarabine

30 mg/m2

Intervention Type: DRUG

Cyclophosphamide

600 mg/m2

Intervention Type: DRUG

CMV Specific Cytotoxic T Lymphocytes (CTL)

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Lucas G. Lucas, MD

Role: STUDY_CHAIR

Milton S. Hershey Medical Center

Other Identifiers

PSHCI #09-045

Identifier Type: -

Identifier Source: secondary_id

31717

Identifier Type: -

Identifier Source: org_study_id