Sponsor study identifier
Secondary identifiers
OTHER · Baylor College of Medicine
interventional
13
1 country
2
Study Start
January 1996
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
July 2014
Actual (reported)Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has come back or not gone away after treatment, including the best treatment known for relapsed Lymphoma. Patients are being asked to volunteer to be in a research study using Epstein Barr virus specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at the time of their diagnosis of the Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. Investigators want to see if it's possible to grow special white blood cells, called T cells, that have been trained to kill EBV infected cells. Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1996
Date type not reportedThis date has not been verified as actual or estimated.
April 8, 2003
Actual (reported)April 9, 2003
Actual (reported)August 2011
Actual (reported)July 2014
Actual (reported)The safety of two IV injections of auto EBV specific CTLs will be determined through adverse event measurement. These CTLs may be marked with the neomycin resistance gene introduced by a retroviral vector.
Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity. The toxicity will be evaluated as per the NCI Common Toxicity criteria version 2.0.Any toxicity scored as Grade 3 or 4 according to this criteria will be classified as an adverse event. If no toxicity is observed in the first three patients then we will enroll another three patients at the next dose level. However, if toxicity is observed in no more than one out of the three patients then three more patients will be enrolled at the same dose level. Now if the toxicity is observed in no more than one out of the six patients then we will advance to the next dose level and enroll three new patients. If toxicity is observed in two or more patients out of six then the dose limiting toxicity (DLT) has been exceeded and the previous dose level will be considered as the maximum tolerated dose (MTD) level.
6 weeks
To determine the feasibility of generating EBV specific cytotoxic T cell lines from patients with active EBV positive Lymphoma including Hodgkin Disease (HD) or Non-Hodgkin Lymphoma (NHL).
Subjects will receive autologous EBV Specific CTLs. Patients that agree will recieve CTLs that have been marked with the neomycin resistance gene.
Each patient will receive two injections, 14 days apart, according to the following dosing schedules: Group One Day 0 2x10\^7 cells/m2 Day 14 2x10\^7 cells/m2 Group Two Day 0 2x10\^7 cells/m2 Day 14 1x10\^8 cells/m2 Group Three Day 0 1x10\^8 cells/m2 Day 14 2x 10\^8 cells/m2 If patients with active disease have stable disease or a partial response by the RECIST criteria at their 8 week or subsequent evaluations they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number as their second injection. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Houston Methodist Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Helen E Heslop, MD
Baylor College of Medicine
13 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2003
First Posted
April 9, 2003
Study Start
January 1996
Date type not reportedThis date has not been verified as actual or estimated.
6 weeks
To determine the survival, immunological efficacy and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
During the course of the study the survival, immunological efficacy and anti-tumor activity of neomycin resistance gene marked EBV specific cytotoxic T-lymphocyte lines will also be studied. In order to gain reasonable insight into the anti-tumor activity and late toxicity the patients will be followed for a total of twelve weeks.In the present case, the chances of observing any late toxicity should be if anything lower, as in this case the CTLs will be derived autologously.
15 years
Contact the study team to confirm eligibility.
Primary Completion
August 2011
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
February 15, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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