Administration of Neomycin Resistance Gene Marked EBV Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma

Trial Information

Administration of Neomycin Resistance Gene Marked EBV Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma

The investigators will take 60-70 ml (12 teaspoonfuls) of blood from the patient to make a B
cell line called a lymphoblastoid cell line or LCL by infecting the blood with a laboratory
strain of EBV called B95. The investigators will then use this EBV infected cell line (which
have been treated with radiation so that they cannot grow) as stimulator cells and mix it
with more blood. This stimulation will train the T cells to kill EBV infected cells and
result in the growth of an EBV specific T cell line. The investigators will then test the T
cells to make sure that they kill the EBV infected cells and not normal cells and freeze
them.

Patients will be entered into one of three different dosing schedules being evaluated. Three
to six patients will be evaluated on each dosing schedule. Escalation will continue until
irreversible or life threatening side effects considered to be related to the T cells are
seen.

The cells will then be thawed and injected into the patients' vein over 10 minutes, after
pretreatment with Tylenol and Benadryl. Tylenol and Benadryl are given to prevent a possible
allergic reaction to the T cell administration. Initially, two doses of T cells will be
given two weeks apart. If after the second infusion there is a reduction in the size of the
patient's lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive
up to six additional doses of the T cells. All of the treatments will be given at Texas
Children's Hospital or the Methodist Hospital.

Patients will be followed in the clinic after the injections. At each visit about 10ml (2
teaspoonfuls) of blood will be taken every other week for 6 weeks after the injection and
then every 3 months for 1 year to monitor blood chemistry and hematology. To learn more
about the way the T cells are working and how long they last in the body, an extra 40 mls (8
teaspoonfuls) of blood will be taken before each infusion and then 24 hours after each
infusion, 3-4 days after each infusion and at 1, 2, 4, and 6 weeks post infusion and then at
3, 6, 9 and 12 months post infusion. The blood may be drawn from the central line at the
time of regular blood tests. This blood will be used to test for the frequency and activity
of EBV specific T cells. A total of at least 122 teaspoons (approximately 40 tablespoons) of
blood will be collected during participation in this study.

If the patient decide to withdraw at any time during the study both samples and data
collected during participation will be maintained.