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Lymphocyte Reinfusion

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ClinicalTrials.gov Identifier: NCT01653834
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Biological: Harvesting and reinfusion of autologous lymphocytes Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
Study Start Date : July 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: all pts with lymphocyte harvesting and reinfusion
pts will be treated with standard temozolmide and radiation, prior to treatment will have lymphocytes harvested (collected and stored) and at week 10 pts lymphocytes will be re-infused. Lymphocyctes will be checked weekly for 14weeks until week 20
Biological: Harvesting and reinfusion of autologous lymphocytes
collect lymphocytes prior to pts starting RT/chemo and put them back after pt completes RT




Primary Outcome Measures :
  1. the feasibility of lymphocyte harvesting and reinfusion [ Time Frame: 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 :
  1. the number of lymphocytes that can be harvested in this pt population [ Time Frame: 10 weeks ]
    the number of lymphocytes harvested per patient

  2. duration of lymphocyte rise following lymphocyte reinfusion [ Time Frame: 10 weeks ]
    how long will lymphocyte counts remain elevated after reinfusion

  3. changes in lymphocyte subtypes following collection and reinfusion [ Time Frame: 10 weeks ]
    changes in lymphocyte subtype between collection and reinfusion as a result of freezing for storage.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653834


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01653834     History of Changes
Other Study ID Numbers: J11162
NA_00068991 ( Other Identifier: JHMIRB )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
lymphopenia

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue