Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
18 Years
N/A
Both
Glioblastoma
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the feasibility of lymphocyte harvesting and reinfusion
Outcome Description:
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.
Outcome Time Frame:
10 weeks
Safety Issue:
Yes
Authority:
United States: Federal Government
Study ID:
J11162
NCT ID:
NCT01653834
Start Date:
July 2012
Completion Date:
July 2014
Related Keywords:
- Glioblastoma
- lymphopenia
- Glioblastoma
Name | Location |
|---|---|
| Johns Hopkins University | Baltimore, Maryland 21205 |
