Phase I/II Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme (COGLI)
N/A
N/A
Both
Glioblastoma Multiforme, GBM, Brain Cancer
Trial Information
Phase I/II Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme (COGLI)
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 patient's T cells to kill cells with CMV on their surface. We then grow
these CMV-T cells by more stimulations with Epstein-Barr virus (EBV)infected cells from the
patient's blood, which also contain the adenovirus with the CMV gene.
When the patient enrolls on this study, they will be assigned a dose of CMV-T cells.
The patient will be given an injection of cells into the vein through an IV line at the
assigned dose. The patient will be followed in the clinic after the injection for 1 to 4
hours.
If after a 6 week evaluation period after the infusion, the patient seems to be experiencing
a benefit (tumor regression confirmed by radiological studies, physical exam and/or
symptoms), they may be able to receive up to six additional doses of the T cells if they
wish. These additional infusions would be at least 1 to 3 months apart and at the same dose
level they received the first time.
Medical tests before treatment--
Before being treated, the patient will receive a series of standard medical tests: Physical
exam, Pregnancy test (if applicable), Blood tests to measure blood cells, kidney and liver
function, Measurements of your tumor by routine imaging studies
Medical tests during and after treatment--
The patient will receive standard medical tests when getting the infusions and after:
Physical exams, Blood tests to measure blood cells, kidney and liver function, Measurements
of your tumor by routine imaging studies 6 weeks after the infusion
To learn more about the way the CMV-T cells are working and how long they last in the body,
blood will be taken on the day of the T-cell infusion, before and at the end of the T-cell
infusion, 1, 2, 4 and 6 weeks after the T-cell infusion and every 3 months for 1 year.
Total time participation for this study will be 1 year.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of subjects with dose limiting toxicity
Outcome Description:
The main aim will be to collect information about the maximum tolerated dosage to evaluate the safety of escalating doses of autologous CMV-specific cytotoxic T-lymphocytes (CTL) in patients with CMV-positive Glioblastoma multiforme (GBM)
Outcome Time Frame:
6 weeks
Safety Issue:
Yes
Principal Investigator
Nabil M. Ahmed, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Center for Cell and Gene Therapy, Baylor College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
26901-COGLI
NCT ID:
NCT01205334
Start Date:
November 2010
Completion Date:
November 2020
Related Keywords:
- Glioblastoma Multiforme
- GBM
- Brain Cancer
- Glioblastoma multiforme
- GBM
- Brain Cancer
- CTL
- Brain Neoplasms
- Glioblastoma
Name | Location |
|---|---|
| Texas Children's Hospital | Houston, Texas |
| The Methodist Hospital | Houston, Texas 77030 |
