Cardiolipin Antibodies |
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Clinical Trial: LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma
This study is currently recruiting patients.
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Purpose
The purpose of this study is to find the largest safe dose of LMP2 specific cytotoxic T cells given after antibody injections, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Lymphoma | Procedure: CD45 antibodies Procedure: EBV specific T cells | Phase I |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Administration of LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients with Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma
Expected Total Enrollment: 18
Study start: October 2003
We will first test a biopsy of the patient's tumor that has already been done to see if tumor cells are EBV positive. If the patient is eligible, we will then take 60-70 ml (12-14 teaspoonfuls) of blood. We will use this blood 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 virus (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 patient's counts are low we may need to obtain additional blood samples to make these cells. We will also take extra blood to freeze in case the patient's immune system is slow to recover after the antibody infusions.
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin lymphoma, regardless of the histological subtype or EBV-associated T/NK cell Lymphoproliferative disease. This includes patients in second or subsequent relapse (or with active disease or in first relapse if immunosuppressive chemotherapy contraindicated).
- Life expectancy of more than 6 weeks.
- No severe intercurrent infection
- Patient, parent/guardian able to give informed consent
- HIV negative
- Bilirubin less than or equal to 3x normal
- AST less than or equal to 5x normal,
- Hgb higher than 8.0 g/L
- Creatinine less than or equal to 2x normal for age
- Patients should have been off other investigational therapy including T cells therapies for one month prior to entry in this study.
- Karnofsky score of over or equal to 50.
- Female patients with reproductive capacity must have a negative pregnancy test.
Exclusion Criteria:
- Patient, parent/guardian unable or unwilling to give informed consent
- HIV positive
- Pregnant women
- Patients with a Karnofsky score of < 50
- Patients with a severe intercurrent infection
- Patients with a life expectancy of <6 weeks
- Patients with a bilirubin of more than 3x normal. AST of more than 5x normal
- Patients with a creatinine of more than 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
Texas Children's Hospital, Houston, Texas, 77030, United States; Recruiting
The Methodist Hospital, Houston, Texas, 77030, United States; Recruiting
Malcolm K Brenner, MD, Study Chair, Baylor College of Medicine
More Information
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: May 3, 2004
ClinicalTrials.gov Identifier: NCT00082225
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

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