Glioblastoma Multiforme Clinical Trial
— COGLIOfficial title:
Phase I/II Administration of CMV (Cytomegalovirus)-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme (COGLI)
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 special immune cells. They may have already thought about being in this
study.
Some patients with GBM show evidence of infection with a virus called Cytomegalovirus before
the time of their diagnosis. CMV is found in the cancer cells of some patients with GBM,
suggesting that it may play a role in causing the disease. The cancer cells infected by CMV
are able to hide from the body's immune system and escape destruction. We want to see if
special white blood cells, called T cells, that have been trained to recognize and kill
special parts of CMV infected cells can survive in the blood and affect the tumor.
We have used this sort of therapy to treat different types of cancer that are positive for
other viruses and have had variable results. Some patients have had responses others did
not. It is not possible for us to predict if this treatment will work for GBM.
The purpose of this study is to find the largest safe dose of CMV-T cells, to learn what the
side effects are, and to see whether this therapy might help patients with GBM.
Status | Terminated |
Enrollment | 2 |
Est. completion date | March 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
United States | The Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, The Methodist Hospital System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with dose limiting toxicity | 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) | 6 weeks | Yes |
Secondary | Patients with a decrease in disease after the CTL infusion | To evaluate the effects of CMV-specific CTL on measurable disease. | 6 weeks | No |
Secondary | Area under the growth curves (AUC) over time for T cell frequencies | To measure the survival and function of CMV-specific CTL in vivo. | 1 year | No |
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