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

NCT01205334 | Terminated Phase 1 DMC

• 1 other identifier: 26901-COGLI
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Glioblastoma Multiforme; GBM; Brain Cancer

Keywords

Glioblastoma multiforme; GBM; Brain Cancer; CTL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Patients with a decrease in disease after the CTL infusion

  6 weeks

• Area under the growth curves (AUC) over time for T cell frequencies

  1 year

Study Arms (1)

Autologous CMV-specific CTL

EXPERIMENTAL

The patient will receive one of the following doses: * 1.5x10\^7 cells/m2 * 4.5x10\^7 cells/m2 * 1.5x10\^8 cells/m2

Biological: Autologous CMV-specific CTL

Interventions

Autologous CMV-specific CTL BIOLOGICAL

CMV-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line with a minimum 20g cannula. The expected volume will be 1-50 cc. At the discretion of the attending physician, subjects can receive repeat infusions of modified T cells at the same dose level as long as they do not have progressive disease (up to a maximum of 6 doses and the minimum interval between repeat infusions is 6 weeks). Infusion procedures and follow-up will be identical to those for the first infusion. Patients, who receive additional doses of CTLs will be monitored exactly like after the 1st CTL infusion.

Also known as: Cytomegalovirus-specific cytotoxic T-Lymphocytes

Autologous CMV-specific CTL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nabil M. Ahmed, MD

  Center for Cell and Gene Therapy, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Pediatric Hematology/Oncology Center for Cell and Gene Therapy

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

US (2)