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Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01653834
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stuart A Grossman, MD
Principal Investigator Affiliation Johns Hopkins University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Procedure: - Lymphocyte harvesting & reinfusion

Lymphocytes will be collected and stored approximately one week prior to initiating concurrent radiation therapy (RT) and temozolomide (TMZ). Two lymphocyte collections are allowed. After the patient has completed 6 weeks of RT/TMZ, all of the collected lymphocytes will be re-infused. After lymphocyte re-infusion, Heme-8 and absolute lymphocyte count (ALC) will be checked per standard of care. The absolute increase in ALC as the primary endpoint will be assessed 4 weeks after lymphocyte re-infusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21287

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