Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme

Stopped early · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme, GBM, Brain Cancer

In brief

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.

Key facts

Study ID

NCT01205334

Run by

Baylor College of Medicine

People needed

2

Starts

2010-11-01

Expected to finish

2012-03-01

Last updated by the study team

2013-08-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Severe intercurrent infection
• Known HIV positivity
• Pregnant or lactating
• History of hypersensitivity reactions to murine protein-containing products.

Where it is running

• Texas Children's Hospital — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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