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

April 30, 2018 updated by: Milton S. Hershey Medical Center

A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GBM Treatment
Drug: Fludarabine
30 mg/m2
Drug: Cyclophosphamide
600 mg/m2
Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
CTL Infusion (3 - 5 x 10E6 cells/kg)

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Study Chair: Kenneth Lucas G. Lucas, MD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

October 28, 2010

Study Completion (ACTUAL)

October 28, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (ESTIMATE)

October 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31717
  • PSHCI #09-045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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