GoldBamboo.com - Knowledge is strong medicine
  

Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. - Article


  Not Signed In - Sign In / Register


Get Your Free Credit Report Right Now!

Zip Code:






Marburg virus

 




Clinical Trial: Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.

This study is currently recruiting patients.

Sponsors and Collaborators: Baylor College of Medicine
Texas Children's Hospital
The Methodist Hospital
Information provided by: Baylor College of Medicine

Purpose

In normal people, the Epstein-Barr (EB) virus infection causes a flu like illness (sometimes called infectious mononucleosis or glandular fever or kissing disease) and usually gets better when the immune system controls the infection. The virus, however, remains hidden in the body for life. After a transplant, while the new immune system is growing back, the EB virus can come out and infect cells and cause them to grow in an uncontrolled manner. Patients can develop fevers, swollen lymph nodes and damage to other organs such as kidneys and lungs. This infection acts like a cancer because the cells infected with EB virus grow very quickly and there is no known effective treatment. This sort of infection will occur in between 10-30% of patients receiving a transplant from a donor who is not a perfect match, and has been fatal in nearly all these cases.

This infection occurs because the immune system cannot control the growth of the cells. We want to see if we can prevent it from happening or treat it by giving patients a kind of white blood cell called T cells that we have grown from the marrow donor. These cells have been trained to attack EB virus infected cells.

The purpose of this study is to evaluate the effectiveness of using EBV specific T cells grown from a Bone Marrow Transplant (BMT) donor to attack EB virus infected cells.

Condition Treatment or Intervention Phase
Bone Marrow Transplantation
Epstein-Barr Virus Infections
 Procedure: Infusion of Cytotoxic T-Lymphocytes
Phase I
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Viral Infections

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Administration of EBV Specific Cytotoxic T Lymphocytes to Recipients of Mismatched-Related or Phenotypically Similar Unrelated Donor Marrow Grafts

Further Study Details: 

Expected Total Enrollment:  20

Study start: May 1993

We will obtain blood from the donor and will first make a B cell line called a lymphoblastoid cell line or LCL by infecting the blood with a laboratory strain of EBV called B95. We will then use this EBV infected cell line (which have been treated with radiation so that they cannot grow) as stimulator cells and mix it with more blood. This stimulation will train the T cells to kill EBV infected cells and result in the growth of an EBV specific T cell line. We will then test the T cells to make sure that they kill the EBV infected cells and not your normal cells and freeze them.

The marrow donor's T cells will be thawed and injected into the patients intravenous line over a period of 10 minutes. We would give one dose of the cells on or after day 45 following transplant. If the patients EBV DNA levels remain high or they have persistent disease they may be eligible to receive up to 5 additional injections of T cells at the original dose at monthly intervals.

After the patient has received the T cells, they will be contacted by the research nurse or another member of the study team weekly for 6 weeks, then once every three months for a year so that we can check on progress. To learn more about the way the T cells are working, an extra 40 mls (about 8 teaspoonfuls) of blood will be taken every two weeks for six weeks after the T cell infusions, and then every three months for one year.

Eligibility

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • All patients receiving a T cell depleted BMT from a mismatched family member or unrelated donor will be eligible for this protocol. In addition patients receiving a matched sibling transplant or T replete transplant may be eligible if they are at high risk of developing EBV LPD because of their underlying disease (e.g Wiskott-Aldrich or Ataxia Telangiectasia) or have a past history of EBVLPD or other EBV associated malignancy.

Exclusion Criteria:

  • Exclusion criteria for BMT will be as detailed in the relevant protocol

Exclusion criteria at time of administration CTLs.

  • GVHD of Grade II or greater.
  • Patients with severe renal disease (i.e., creatinine clearance less than half normal for age).
  • Patients with severe hepatic disease (bilirubin greater than twice normal, or SGOT greater than 3 x normal).
  • Patients with a severe intercurrent infection.
  • Life expectancy <6 weeks

Location and Contact Information


Texas
      Texas Children's Hospital, Houston,  Texas,  77030,  United States; Recruiting
Helen E Heslop, MD  832-824-4662    hheslop@bcm.tmc.edu 
Helen E Heslop, MD,  Principal Investigator

      The Methodist Hospital, Houston,  Texas,  77030,  United States; Recruiting
Helen E Heslop, MD  832-824-4662    hheslop@bcm.tmc.edu 
Helen E Heslop, MD,  Principal Investigator

More Information

Study ID Numbers:  H6676; ETNA
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  April 11, 2003
ClinicalTrials.gov Identifier:  NCT00058812
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $30 a year, a savings of 70% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Marburg virus.

November 25, 2009



Page Updated: October 1, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Health Forums

Copyright © 2004-2009 - Anaconda Partners LLC - All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.