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

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ClinicalTrials.gov Identifier: NCT00990496
Recruitment Status : Terminated (Accrual goals not met)
First Posted : October 6, 2009
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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

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  (Clinical Trial)
Actual Enrollment : 25 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 : October 28, 2010
Actual Study Completion Date : October 28, 2010

Resource links provided by the National Library of Medicine


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)




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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00990496


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

Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00990496     History of Changes
Other Study ID Numbers: 31717
PSHCI #09-045
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Keywords provided by Milton S. Hershey Medical Center:
Glioblastoma multiforme
GBM
Cytomegalovirus
CMV
Cytotoxic T lymphocyte
CTL

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