Status:
TERMINATED
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
5-65 years
Phase:
PHASE1
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 ...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00990496
Start Date
September 1 2009
End Date
October 28 2010
Last Update
May 2 2018
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