Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-31 @ 3:21 PM
Study NCT ID:
NCT01653834
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NA_00068991 | OTHER | JHMIRB | View |