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Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. Clinical research trials and Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.. Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. clinical trial. Participants typically obtain the most effective healthcare available for their Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma. condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.  Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.
Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.
For Condition: Hodgkin Disease
Status: Recruiting
Sponsor(s): Baylor College of Medicine , Texas Children's Hospital,The Methodist Hospital
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion criteria - Any patient regardless of age or sex, with EBV positive Hodgkin's Lymphoma regardless of the histological subtype and: - In second or subsequent relapse (or first relapse if immunosuppressive chemotherapy contraindicated) (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. Exclusion criteria - 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.
Total Enrollment: 36
Location and Contact Information:
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Helen Heslop 832-824-4662
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Helen Heslop 832-824-4662
Additional Information:
Study ID Numbers: H9936; ALASCER
Study Start Date: January 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062868
Other Hodgkin Disease Studies:
1. Pegfilgrastim PBPC Mobilization Study
2. Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.
3. A Safety/Efficacy Study of SGN-30 (Antibody) in Patients with Refractory or Recurrent CD30+ Hematologic Malignancies
4. Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
5. Safety and efficacy of an investigational drug in the prevention of thrombocytopenia in recurrent or refractory non-Burkitt's, non-Hodgkin's lymphoma (NHL) or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine and Cisplatin) chemotherapy
Related Studies:
Other Hodgkin Disease Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.
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