Text Size

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

This study has been terminated.
(Accrual goals not met)
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00990496
First received: October 5, 2009
Last updated: August 18, 2011
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Glioblastoma Multiforme
 Drug: Fludarabine
Drug: Cyclophosphamide
Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine safety of allogeneic CTL infusions in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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)
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.

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990496

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

No publications provided

Responsible Party: Kenneth G. Lucas, MD, Penn State University
ClinicalTrials.gov Identifier: NCT00990496     History of Changes
Other Study ID Numbers: 31717, PSHCI #09-045
Study First Received: October 5, 2009
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
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 monophosphate
Fludarabine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on June 13, 2013