Clinical trial NCT01653834: Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
Official title: Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: lymphopenia
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the feasibility of lymphocyte harvesting and reinfusion
timeFrame: 10 weeks
Secondary outcomes:
measure: the number of lymphocytes that can be harvested in this pt population
timeFrame: 10 weeks
measure: duration of lymphocyte rise following lymphocyte reinfusion
timeFrame: 10 weeks
measure: changes in lymphocyte subtypes following collection and reinfusion
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Stuart A Grossman, MD
role: STUDY_CHAIR
References: