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Administration of EBV-Specific T-Lymphocytes to Patients With EBV-Positive Nasopharyngeal Carcinoma

Phase 1
Not Enrolling
Head and Neck Cancer

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Trial Information

Administration of EBV-Specific T-Lymphocytes to Patients With EBV-Positive Nasopharyngeal Carcinoma

We will first test a biopsy of the tumor (that has already been done) to see if your tumor
cells are EBV positive. If the patient is eligible, we will then take 60-70 ml (12-14
teaspoons) of blood from them. We will use this blood to grow more of the T cells in the
laboratory. We will first grow an EBV-infected cell line by infecting the blood with EBV
virus. This line will then be irradiated so it cannot grow and used to stimulate the T
cells. This stimulation will train the T cells to kill cells with EBV on their surface. We
will then grow these EBV-specific CTLs by more stimulation with EBV infected cells and a
growth factor called Interleukin 2. Next, we will test the T cells to make sure that they
kill the EBV-infected cells. If the number of T cells produced is low, we may need to obtain
additional blood samples to make these cells.

The cells (which are the patient's own T cells) will be injected into them over 10 minutes,
after pretreatment with Tylenol and Benadryl. A total of two doses will be given two weeks
apart. All of the Treatments will be given by the Center for Cell and Gene Therapy at Texas
Children's Hospital or the Methodist Hospital.

We will follow the patient in the clinic after the injections. To learn more about the way
the T cells are working and how long they last in the body, an extra 10-60 mls (2-12
teaspoons) of blood will be taken before the infusion and 3-4 days after the infusion (this
is optional). Up to 40 ml (8 teaspoons) of blood will also be drawn at 1, 2, 4 and 6 weeks
post-infusion, and then at 3, 6, 9, and 12 months. The blood may be drawn from the patient's
central line at the time of the regular blood tests. We will use this blood to look at the
immune response to the patient's cancer. Over the course of the study, up to 29 tablespoons
of blood will be drawn.

Patients will also have repeat scans at 8 weeks after the first injections. If these show
stable or improving disease they may (if the patient wishs) receive up to 6 extra doses of
cells. These would be given every 1-3 months. If the patient has additional injections of
cells after the first two infusions, we will take extra blood tests before each infusion, at
the end of each infusion, 3-4 days after each infusion (day optional depending on patient
preference), and at 1 and 2 weeks after each infusion. We will also do an extra scan between
1 and 3 months after the last infusion. Follow up will then continue every 3 months and will
continue until 12 months after the last infusion.

Inclusion Criteria:

- 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.

Exclusion Criteria:

-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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of two IV injections of autologously derived Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTLs)

Outcome Description:

Patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Helen E. Heslop, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

August 2001

Completion Date:

June 2012

Related Keywords:

  • Head and Neck Cancer
  • recurrent nasopharyngeal cancer
  • stage II nasopharyngeal cancer
  • stage III nasopharyngeal cancer
  • stage IV nasopharyngeal cancer
  • Head and Neck Neoplasms
  • Nasopharyngeal Neoplasms



Texas Children's HospitalHouston, Texas  
The Methodist HospitalHouston, Texas  77030