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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas|
- the feasibility of lymphocyte harvesting and reinfusion [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]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.
- the number of lymphocytes that can be harvested in this pt population [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]the number of lymphocytes harvested per patient
- duration of lymphocyte rise following lymphocyte reinfusion [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]how long will lymphocyte counts remain elevated after reinfusion
- changes in lymphocyte subtypes following collection and reinfusion [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]changes in lymphocyte subtype between collection and reinfusion as a result of freezing for storage.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: all pts with lymphocyte harvesting and reinfusion
pts will be treated with standard temozolmide and radiation, prior to treatment will have lymphocytes harvested (collected and stored) and at week 10 pts lymphocytes will be re-infused. Lymphocyctes will be checked weekly for 14weeks until week 20
Biological: Harvesting and reinfusion of autologous lymphocytes
collect lymphocytes prior to pts starting RT/chemo and put them back after pt completes RT
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653834
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|