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

October 5, 2009
August 18, 2011
September 2009
February 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00990496 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • 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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00990496
31717, PSHCI #09-045
Yes
Kenneth G. Lucas, MD, Penn State University
Penn State University
Not Provided
Study Chair: Kenneth Lucas G. Lucas, MD Milton S. Hershey Medical Center
Penn State University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP