Safety Study of Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells to Treat Relapsed EBV-Positive Lymphoma,
Status: | Archived |
---|---|
Conditions: | Cancer, Blood Cancer, Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
The Administration of Neomycin Resistance Gene Marked EBV Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma.
Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus
that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their
diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may play a
role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are
able to hide from the body's immune system and escape destruction. The investigators want to
see if they can grow special white blood cells, called T cells, that have been trained to
kill EBV infected cells and then give them back to the patient. To find out how long these
cells last the investigators may put a marker gene into them so they can track them. Gene
marking is optional in this study. Eligible patients can participate without the gene
marking if they choose.
The purpose of this study is 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 Hodgkin disease and non-Hodgkins 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.
For patients who agree to gene marking (this is optional), the investigators will mark these
cells with a special bacterial marker gene. The investigators will use a mouse virus
(retrovirus) that has been changed to stop it from causing infection. The marker, a gene
called Neo, is put inside this special virus.
The cells will be 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. A total of two doses will be given two weeks apart. 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 the patients' blood chemistry and hematology.
For patients who agreed to gene marking, an extra 8 teaspoons (40 mls) of blood will be
taken before each infusion, 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) then
once every 6 months for the first 5 years and then yearly thereafter for the next 10 years.
The investigators will use this blood to test for the frequency and activity of EBV specific
T cells. That is, to learn more about the way the T cells are working and how long they last
in the body.
The investigators will also use this blood to see if there are any long term side effects of
gene transfer. Patients who received cells that have a marker gene will need to be followed
(seen in clinic or contacted by a research nurse) at least every six months for the next
five years and then yearly thereafter for the next ten years so the investigators can see if
there are any long term side effects of the gene transfer.
We found this trial at
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Baylor School of Medicine Baylor College of Medicine is a health sciences university that creates...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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