Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/9/2018 |
| Start Date: | July 2012 |
| End Date: | March 2014 |
This research study is being done to see if lymphocytes can be collected from patients with
high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are
cells that normally circulate in the blood and are an essential part of the immune system).
The investigators goal is to store these and give them back to the patient after radiation is
completed. This is part of a larger effort that will attempt to preserve the immune system
from the effects of radiation and chemotherapy.
high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are
cells that normally circulate in the blood and are an essential part of the immune system).
The investigators goal is to store these and give them back to the patient after radiation is
completed. This is part of a larger effort that will attempt to preserve the immune system
from the effects of radiation and chemotherapy.
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 and
chemotherapy.
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 and
chemotherapy.
Inclusion Criteria:
- • Age≥18 year
- New diagnosed high grade glioma
- Post-operative treatment with standard RT/TMZ
- Karnofsky performance status ≥ 60%
- Normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000,
and absolute lymphocyte count ≥ 1000 prior entry to this study. Blood product
transfusions are allowed.
Exclusion Criteria:
- Prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents
or hormonal therapy for their brain tumor are excluded. Glucocorticoid therapy is
allowed.
- Fresh CNS bleed, current anticoagulation use; and anti-VEGF therapy in past 6 weeks
are excluded.
- Patients must not have taken an ACE inhibitor within last 24 hours prior to apheresis.
We found this trial at
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