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Neoplasms by Histologic Type

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Antibodies

Immunoglobulins

Immunologic Factors

Patients receiving CTLs as therapy for relapsed Lymphoma or who are at high risk for relapse or patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

A fixed dose of CD45 MAb (400ug/kg over 4 hours daily times 4 given over 2 daily IV infusions) will be used.

The antibody solution is administered by a syringe pump in incremental doses, 0.2-0.8 mg in the first hour and up to 10 mg/hr thereafter, for a maximum infusion time of 8 hrs.

CD45 antibodies

The following dose levels will be evaluated: Each patient will receive 1 injection, according to the following dosing schedules:

2 x 10e7 cells/m2 5 x 10e7 cells/m2

1 x 10e8 cells/m2

EBV specific T cells

Helen E Heslop, MD

Patients have a type of cancer called Hodgkin's lymphoma or non-Hodgkin's lymphoma, which has come back or not gone away or is at high risk for coming back after treatment, including the best treatment investigators know for this disease. Investigators are asking the patient to volunteer to be in a research study using a new experimental therapy consisting of special immune system cells called LMP2 specific cytotoxic T lymphocytes in combination with a special protein called a monoclonal antibody.

Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of the lymphoma. EBV is found in the cancer cells of up to half the patients with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor.

The investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. They grew T cells in the laboratory that recognized all 9 proteins and were able to prevent and treat post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma the tumor cells only express 2 EBV proteins. In a previous study investigators made T cells that recognized all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial response to this therapy but no patients had a complete response. Investigators think one reason may be that many of the T cells reacted with proteins that were not on the tumor cells. They are now trying to find out if they can improve this treatment by growing T cells that only recognize one of the proteins expressed on Lymphoma cells called LMP-2. These special T cells are called LMP-2 specific cytotoxic T-lymphocytes (CTLs).

In this study investigators also are trying to see if they can improve these results by treating patients first with a special protein called an antibody and then giving the EBV specific T cells. The reason for doing this is that EBV specific T cells have worked very well in bone marrow transplant patients to prevent and treat EBV cancers. These patients have very few of their own immune cells when they are given the trained T cells and therefore there is a lot of space for the trained cells to grow. Investigators hope that they can improve the effect of the trained T cells in Hodgkin disease and non-Hodgkin Lymphoma patients by first temporarily removing the patient's own T cells before giving the trained cells.

Investigators first tested a biopsy of the tumor that has already been done to see if the tumor cells are EBV positive. They then got permission to take up to 60ml (12 teaspoonfuls) of blood from the patient or their donor on one or two occasions and used this blood to grow T cells in the laboratory. They first grew a special type of cell called dendritic cells stimulate the T cells and put a specially produced human virus (adenovirus) that carries the LMP-2a gene into the dendritic cells. These dendritic cells were then treated with radiation so they could not grow. They were then used to stimulate T cells. This stimulation trained the T cells to kill cells with LMP-2a on their surface. Investigators then grew these LMP-2a specific CTLs by more stimulation with EBV infected cells (which were made from the patient's blood or their donor's blood by infecting them with EBV in the laboratory). The investigators also put the adenovirus that carries the LMP2 gene into these EBV infected cells to increase the amount of LMP2 that these cells have. Again, these EBV infected cells were treated with radiation so they could not grow. Once sufficient numbers of T cells were made, investigators tested them to make sure they kill cells with LMP2a on their surface. These cells are now ready to give to the patient if they agree to being on this study.

Investigators also took up to 500 ml (2 1/2 cups) of extra blood from the patient or their donor, which were frozen. In case the patient's own cells do not recover as expected after the antibody and cell infusions, these cells can be thawed and given back to the patient.

If the patient agrees to this treatment they will get treated with the CD45 antibodies for 4 days in a row and then 2-3 days later get a dose of LMP2 specific CTLs.

The CD45 antibodies will be given to the patient through a vein for 6-8 hours and monitored for at least 6 hours after the infusion. After the infusion The patient will be checked for the levels of CD45 in the blood at 24 hours (optional) and/or at 48-72 hours after the last infusion to check the level is low enough to give the patient the CTLs.

The CTLs will be thawed and injected through a central line, if the patient has one, or through a vein in their arm over 10 minutes, after pretreatment with Tylenol and Benadryl. We will then monitor them in clinic for 4 hours after the injection.

All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or the Methodist Hospital. We will follow the patient in the clinic after the CTL injection. If there is a reduction in the size of the lymphoma on CT or MRI scans as assessed by a radiologist, they can receive up to six additional doses of the T cells if they wish.

LMP2a-Specific Cytotoxic T-Lymphocytes, Lymphoma (ACDAL)

Administration of LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients With Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma

To determine the safety of autologous/syngeneic or allogeneic LMP-2 specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (Mab) in patients with EBV positive Hodgkin's disease (HD) or non-Hodgkin's lymphoma (NHL).

Obtain information on expansion, persistence and anti-tumor effects of (CTL) given after lymphodepletion with CD45 monoclonal antibody (Mab) in patients with EBV positive Hodgkin's disease or non-Hodgkin's lymphoma.

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Baylor College of Medicine

Professor

Hodgkin Disease

Lymphoma, Non-Hodgkin

Hodgkin Lymphoma

Antineoplastic Agents

Vinorelbine

Patients are dosed on Day 1 and Day 8 of a 21-day cycle.

Patients are dosed on Day 1 of a 21-day cycle.

John Sarantopoulos, MD

Gerald Batist, MD

Anthony W. Tolcher, MD

This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.

The objectives of this study are:

* To assess the safety and tolerability of treatment with VLI.
* To determine the maximum tolerated dose (MTD) of VLI.
* To characterize the pharmacokinetic (PK) profile of VLI.
* To explore preliminary tumor response of VLI.

Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Spectrum Pharmaceuticals, Inc

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Syndrome

Lymphadenopathy

Autoimmune Lymphoproliferative Syndrome

Genetic Diseases, Inborn

Autoimmune Diseases

Fluorodeoxyglucose F18

V. Koneti Rao, M.D.

This study will evaluate the usefulness of FDG-PET scanning in distinguishing autoimmune lymphoproliferative syndrome (ALPS) from lymphoma. Lymphoma is cancer of the lymph system. ALPS is a condition involving persistent enlargement of the lymph glands, spleen, or liver, and a range of other problems relating to blood cell counts and abnormal immune activity, in which the immune system attacks healthy tissues. People with ALPS particularly those with an abnormal Fas gene also have an increased risk of developing lymphoma. The Fas gene codes for a protein that causes immune cells called lymphocytes to die when they are no longer needed.

FDG-PET is a new nuclear imaging test that is very effective in detecting lymphoma. It is important to identify these cancers as quickly as possible, since some are very curable when caught early. Since ALPS and lymphoma share several common characteristics, a reliable, non-invasive method of distinguishing the two, such as FDG-PET might offer, is crucial. FDG-PET uses a radioactive sugar molecule to produce images that show the metabolic activity of tissues. Because cancer cells grow and divide more rapidly than normal cells, they metabolize more sugar for fuel. This increased activity identifies them as cancer in FDG-PET scanning. For this procedure, the subject is injected with the sugar molecule and lies in a doughnut-shaped machine (PET camera) for the imaging.

Adults and children 10 years old or older with ALPS, with or without lymphoma, may be eligible for this study. Candidates will be screened with a physical examination, blood tests, and computed tomography (CT) scan.

Participants will have an FDG-PET scan and a DEXA scan. The DEXA scan measures fat and non-fat tissue and is used help interpret the FDG-PET results. For this test, the subject lies on a table while a fast X-ray is taken from head to toe.

Patients who develop signs or symptoms suggesting the development or recurrence of lymphoma (such as further enlargement of lymph glands, unexplained fever or weight loss, or abnormal scans) may undergo a tissue biopsy. For this procedure, a small piece of lymph or other tissue is surgically removed for examination under the microscope. In addition, patients who develop these symptoms may be asked to undergo additional FDG-PET scans up to two a year in patients without lymphoma, and as many as needed in patients with lymphoma to evaluate their response to treatment and guide future therapy.

The Autoimmune Lymphoproliferative Syndrome (ALPS) is an inherited disorder associated with defective lymphocyte apoptosis, which is clinically characterized by prominent non-malignant lymphadenopathy, hepatosplenomegaly and overt autoimmune diseases such as hemolytic anemia, autoimmune thrombocytopenia and neutropenia. Additionally, ALPS patients have a significantly increased risk of developing non-Hodgkin's and Hodgkin's lymphoma.

The diagnosis of lymphoma is particularly troublesome in ALPS because many ALPS manifestations overlap with clinical features suggestive of lymphoma. Therefore, individuals with ALPS may undergo repeated biopsies during the course of the disease. Finding a non-invasive test that can predictably discriminate benign from malignant lymphadenopathy in ALPS, and that can help discern whether a more invasive lymph node biopsy is necessary, would be very desirable.

Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) is an increasingly used non-invasive imaging technique for staging and monitoring therapeutic responses in patients with lymphoma. This technique might be able to assist us in distinguishing whether enlargement of lymph nodes is due to ALPS versus ALPS associated lymphoma. However, FDG-PET has not been studied in patients with ALPS. This study will first explore whether ALPS patients with lymphadenopathy show FDG uptake. If uptake is shown, the study will obtain initial quantitative data to compare FDG uptake in ALPS patients with lymphadenopathy, and ALPS patients with associated lymphoma. The ultimate goal is to assess FDG-PET as a reliable non-invasive method to differentiate lymphadenopathy due to ALPS versus that of ALPS associated lymphoma.

Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) to Evaluate Autoimmune Lymphoproliferative Syndrome (ALPS) and ALPS-associated Lymphoma

Study of Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Evaluation of the Autoimmune Lymphoproliferative Syndrome (ALPS) and ALPS-Associated Lymphoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LMP2a-Specific Cytotoxic T-Lymphocytes, Lymphoma (ACDAL)	NCT00082225	Lymphoma	CD45 antibodies EBV specific T ...	-	Baylor College of Medicine
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease	NCT00364676	Tumors Hodgkins Diseas... Non-Hodgkins Ly...	VLI VLI	18 Years -	Spectrum Pharmaceuticals, Inc
LMP2a-Specific Cytotoxic T-Lymphocytes, Lymphoma (ACDAL)	NCT00082225	Lymphoma	CD45 antibodies EBV specific T ...	-	Baylor College of Medicine
LMP2a-Specific Cytotoxic T-Lymphocytes, Lymphoma (ACDAL)	NCT00082225	Lymphoma	CD45 antibodies EBV specific T ...	-	Baylor College of Medicine
Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) to Evaluate Autoimmune Lymphoproliferative Syndrome (ALPS) and ALPS-associated Lymphoma	NCT00068146	Lymphoprolifera... Lymphoma		8 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for hodgkins

Every month we try and update this database with for hodgkins cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hodgkins

Every month we try and update this database with for hodgkins cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hodgkins cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.