Gene Marked Cytotoxic T-cells for Patients with Relapsed Hodgkin's Lymphoma - Article Caverject; Edex Kit
Clinical Trial: Gene Marked Cytotoxic T-cells for Patients with Relapsed Hodgkin's Lymphoma
This study is currently recruiting patients.
The purpose of this study is to find the largest safe dose of LMP-2a specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease.
Gene marking is optional in this study. Eligible patients can participate without the gene marking if they choose.
|Condition||Treatment or Intervention||Phase|
|Hodgkin Disease || Procedure: Injection of EBV Specific Cytotoxic T-Lymphocytes ||Phase I |
MedlinePlus related topics: Hodgkin's Disease
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Expected Total Enrollment: 36
Study start: January 2003
If the patient is eligible for this study, we will take 60-70 ml (12 teaspoonfuls) of blood and use this to grow T cells. We will first grow a special type of cell called dendritic cells which will stimulate the T cells and we will put a specially produced human viruses (adenovirus) that carries the LMP-2a gene into the dendritic cells. These dendritic cells will then be treated with radiation so they cannot grow. They will then be used to stimulate T cells. This stimulation will train the T cells to kill cells with LMP-2a on their surface. We will then grow these LMP-2a specific CTLs by more stimulation with EBV infected cells (which we will make from the patients blood by infecting them with EBV in the laboratory). We will also put the adenovirus that carries the LMP2 gene into these EBV infected cells so that we increase the amount of LMP2 which these cells have. Again, these EBV infected cells will be treated with radiation so they cannot grow. Once we have made sufficient numbers of T cells we will test them to make sure they kill cells with LMP2a on their surface. If the patients counts are low we may need to obtain additional blood samples to make these cells.
For patients who agree to gene marking (this is optional): To learn how long these T cells last after we have given them, we will mark them with a special bacterial marker gene. We will use a mouse virus (retrovirus) that has been changed to stop it from causing infection. The marker, a gene called Neo, is put inside this special virus, which drops off the gene inside the T cell.
The cells will be injected into the patient over 10 minutes. A total of two doses will be given two weeks apart. This is a dose escalation study which means that for some patients the second dose may be larger than the first. All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or The Methodist Hospital.
The patient will either be seen in the clinic or will be contacted by a research nurse yearly for 5 years or 15 years for patients who agreed to gene marking. To learn more about the way the T cells are working and how long they last in the body, an extra 40 mls (8 teaspoonfuls) of blood will be taken every other week for 6 weeks after the injection, then every 3 months for 1 year, then yearly for 5 years or 15 years (for patients who agreed to gene marking. The blood may be drawn from the patients central line at the time of regular blood tests. We will use this blood to look for the marker gene to see how long the T cells last and to look at the immune response to the patients cancer.
Genders Eligible for Study: Both
- Any patient regardless of age or sex, with EBV positive Hodgkin's Lymphoma regardless of the histological subtype
- Multiply relapsed patients currently in remission who have a high risk of relapse. and:
- In second or subsequent relapse (or first relapse if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)
(GROUP A) OR
- In remission or with minimal residual disease status after autologous SCT for Hodgkin's Lymphoma. (GROUP B)
- Patients with life expectancy > / = 6 weeks.
- Patients with a Karnofsky score of great than or equal to 50
- No severe intercurrent infection.
- Patient, parent/guardian able to give informed consent.
- Patients with bilirubin < / = 3x normal, AST < / = 5x normal, and Hgb > 8.0.
- Patients with a creatinine < / = 2x normal for age
- Patients should have been off other investigational therapy for one month prior to entry in this study.
- Patients with a life expectancy of < 6 weeks.
- Patients with a Karnofsky score of < 50.
- Patients with a severe intercurrent infection.
- Patients with bilirubin > 3 x normal. AST > 5 x normal or abnormal prothrombin time.
- Patients with a creatinine > 2x normal for age
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
Location and Contact Information
Texas Children's Hospital, Houston, Texas, 77030, United States; Recruiting
Helen E Heslop, MD, Principal Investigator
The Methodist Hospital, Houston, Texas, 77030, United States; Recruiting
Helen E Heslop, MD, Principal Investigator
Record last reviewed: November 2004
Last Updated: November 3, 2004
Record first received: June 17, 2003
ClinicalTrials.gov Identifier: NCT00062868
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005