Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
The patients blood will be collected (apheresis) before starting the patients planned
standard of care radiation therapy and chemotherapy:
- An IV will be inserted into the vein in the patients arm.
- The blood will be sent to a machine that removes the lymphocytes and returns the
rest to the patient.
- This procedure will last from 1 hour and 15 minutes to 4 hours.
- During this time the patient will also be treated with a blood thinner to prevent the
blood from clotting in the machine.
- The lymphocytes will be counted and stored. If an insufficient number were collected,
we will ask for another similar collection in about 1 week.
- After the patient has completed the full 6 weeks of radiation, all of the lymphocytes
will be returned to the patient through a simple intravenous infusion. A larger
intravenous access (i.e. midline) might be needed. Any cells that are not reinfused
will be stored for 1 year and then discarded.
- Study bloods (10 ml) will be collected at the time of lymphocyte collection, prior
lymphocyte reinfusion, and then every 2 weeks until week 20th. These blood samples
will be stored and used for future analysis.
Blood counts are obtained weekly as part of standard care for patients with this kind of
brain tumor. For the first 14 weeks after the lymphocyte reinfusion we will be doing some
extra tests on the routinely collected blood to see how the effective the reinfused
lymphocytes are in raising the patients lymphocyte counts. These results will be available
to the patients treating physician.
At no time will this study interfere with the patients planned standard of care radiation
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the feasibility of lymphocyte harvesting and reinfusion
this will be considered a feasible approach if 5 of the 10 patients to be accrued have an absolute lymphocyte count increase of 300 cells per mm3 at 4 weeks after reinfusion.
United States: Federal Government
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