T-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer, NPC

Completed · Phase 1

Conditions studied: Head and Neck Cancer

In brief

Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not gone away or is at high risk for coming back after treatment (including the best treatment we know for nasopharyngeal cancer). We are asking patients to volunteer to be in a research study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new experimental therapy. Most patients with nasopharyngeal cancer show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer, suggesting that it may play a role in causing this cancer. The cancer cells infected by EBV 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 kill EBV-infected cells can survive in the patient's blood and affect the tumor. We have treated other patients with different EBV positive cancers and have had variable results. Some patients have had some response to the treatment. Some patients have been cured by the treatment. It is not possible for us to predict if this treatment will work for nasopharyngeal cancer. The purposes of this study are to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are, and to see whether this therapy might help patients with nasopharyngeal cancer.

Key facts

Study ID

NCT00609219

Run by

Baylor College of Medicine

People needed

25

Starts

2001-08-01

Expected to finish

2012-06-01

Last updated by the study team

2012-10-10

Who can join

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

You may qualify if…

• All patients with NPC in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive disease) in whom the EBV genome or antigens have been demonstrated in tissue biopsies will be eligible for this trial. -Patients with a life expectancy >6 weeks
• Patients with a Karnofsky score of >/= 50
• No severe intercurrent infection.
• Patient, parent/guardian able to give informed consent.
• Patients with bilirubin <2x normal, SGOT <3x normal, and Hgb >8.0
• Patients with a creatinine <2x normal for age
• Patients should have been off other investigational therapy for one month prior to entry in this study.

You may not qualify if…

• Patients with a life expectancy of <6 weeks. -Patients with a Karnofsky score of < 50. -Patients with a severe intercurrent infection. -Patient, parent/guardian unable to give informed consent. -Patients with a bilirubin >2x normal. SGOT >3x normal or abnormal prothrombin time. -Patients with a creatinine >2x normal for age -Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
• Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigators discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.

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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