Status:
TERMINATED
Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Glioblastoma Multiforme
GBM
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
Patients have a type of brain cancer called glioblastoma multiforme. Because most GBMs come back after standard therapy, patients are being asked to volunteer to take part in a research study using sp...
Detailed Description
To generate CMV-T cells we put a specially produced carrier virus (adenovirus) that carries one CMV gene into the patient's blood monocytes or dendritic cells. These cells are then used to train the p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B).
- CMV-positive GBM
- CMV seropositive
- Life expectancy 6 weeks or greater
- Karnofsky/Lansky score 50 or greater
- Patient or parent/guardian capable of providing informed consent
- Bilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater
- Pulse oximetry of 90% or greater on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.
- Patients should have been off other investigational antineoplastic therapy for one month prior to entry in this study.
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- EXCLUSION CRITERIA:
- Severe intercurrent infection
- Known HIV positivity
- Pregnant or lactating
- History of hypersensitivity reactions to murine protein-containing products.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01205334
Start Date
November 1 2010
End Date
March 1 2012
Last Update
August 26 2013
Active Locations (2)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030
2
The Methodist Hospital
Houston, Texas, United States, 77030