A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
5 Years
65 Years
Both
Glioblastoma Multiforme
Trial Information
A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Kenneth Lucas G. Lucas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Milton S. Hershey Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
31717
NCT ID:
NCT00990496
Start Date:
September 2009
Completion Date:
February 2011
Related Keywords:
- Glioblastoma Multiforme
- Glioblastoma multiforme
- GBM
- Cytomegalovirus
- CMV
- Cytotoxic T lymphocyte
- CTL
- Glioblastoma
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