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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00990496
Recruitment Status : Terminated (Accrual goals not met)
First Posted : October 6, 2009
Last Update Posted : August 19, 2011
Information provided by:
Penn State University

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Fludarabine Drug: Cyclophosphamide Biological: CMV Specific Cytotoxic T Lymphocytes (CTL) Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
Study Start Date : September 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • Patients must have a histopathologic diagnosis of GBM.
  • Patients from 5 to 65 years of age with GBM.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990496

Sponsors and Collaborators
Penn State University
Study Chair: Kenneth Lucas G. Lucas, MD Milton S. Hershey Medical Center

Responsible Party: Kenneth G. Lucas, MD, Penn State University Identifier: NCT00990496     History of Changes
Other Study ID Numbers: 31717
PSHCI #09-045
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: August 2010

Keywords provided by Penn State University:
Glioblastoma multiforme
Cytotoxic T lymphocyte

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists