Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

Not Applicable

Completed

• Conditions: Glioblastoma
• Interventions: Procedure: Lymphocyte harvesting & reinfusion

• Registration Number: NCT01653834
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymphocyte harvesting & reinfusion	Lymphocyte harvesting & reinfusion	Patients with a newly diagnosed high grade glioma (Grade III or IV), have a post-operative treatment plan that includes standard radiation and temozolomide, and have normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study are eligible for enrollment.

Primary Outcome Measures

Name	Time	Method
the feasibility of lymphocyte harvesting and reinfusion	10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
the number of lymphocytes that can be harvested in this pt population	10 weeks	the number of lymphocytes harvested per patient
duration of lymphocyte rise following lymphocyte reinfusion	10 weeks	how long will lymphocyte counts remain elevated after reinfusion
changes in lymphocyte subtypes following collection and reinfusion	10 weeks	changes in lymphocyte subtype between collection and reinfusion as a result of freezing for storage.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States