Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

Completed · Not applicable

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT01653834

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

10

Starts

2012-07-01

Expected to finish

2014-03-01

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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