Lymphocyte Reinfusion

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01653834
First received: July 12, 2012
Last updated: June 14, 2013
Last verified: June 2013
  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.


Condition Intervention
Glioblastoma
Biological: Harvesting and reinfusion of autologous lymphocytes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • the feasibility of lymphocyte harvesting and reinfusion [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    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:
  • the number of lymphocytes that can be harvested in this pt population [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    the number of lymphocytes harvested per patient

  • duration of lymphocyte rise following lymphocyte reinfusion [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    how long will lymphocyte counts remain elevated after reinfusion

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


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653834

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

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01653834     History of Changes
Other Study ID Numbers: J11162, NA_00068991
Study First Received: July 12, 2012
Last Updated: June 14, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Clinical Research Office

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

ClinicalTrials.gov processed this record on July 26, 2014