Expired Study
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Houston, Texas 77030


Purpose:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's or donor's a cytotoxic T lymphocytes in the laboratory and reinfusing them may cause a stronger immune response to kill Epstein-Barr virus-associated cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of autologous or donor cytotoxic T-lymphocytes in treating patients with relapsed Epstein-Barr virus-associated Hodgkin's lymphoma or non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the safety of autologous or allogeneic LMP2A-specific cytotoxic T-lymphocytes in patients with relapsed Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma. - Determine the survival and immune function of patients treated with this regimen. - Determine the antiviral and antitumor effects of this regimen in these patients. - Obtain preliminary information on the safety of and response to an extended dosage of this regimen in these patients. OUTLINE: Peripheral blood is collected from the patient or a donor and allogeneic or autologous dendritic cells (DC) are generated over 7 days using sargramostim (GM-CSF) and interleukin-4 (IL-4). DC are transduced with recombinant AdLMP2A and matured with GM-CSF, TNFa, PGE-1, and IL-4 over 2 days to stimulate cytotoxic T-lymphocytes (CTL). Patients receive LMP2A-specific CTL IV over 1-10 minutes on days 0 and 14. Cohorts of 3-6 patients receive escalating doses of LMP2A-specific CTL. Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of LMP2A-specific CTL IV over 1-10 minutes once monthly. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma - Any histological subtype - Meets criteria for 1 of the following: - Second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy is contraindicated (e.g., patients who develop Hodgkin's lymphoma after a prior solid organ transplant, who have lymphoma as a second malignancy, or who have relapsed multiple times AND at high risk of relapse) (group A) - In remission OR with minimal residual disease after autologous stem cell transplantation for Hodgkin's or non-Hodgkin's lymphoma or lymphoepithelioma (group B) - In remission OR with detectable disease after allogeneic stem cell transplantation (group C) PATIENT CHARACTERISTICS: Age - Any age Performance status - Karnofsky 50-100% Life expectancy - At least 6 weeks Hematopoietic - Hemoglobin greater than 8.0 g/dL - More than 50% donor chimerism in either peripheral blood or bone marrow after allogeneic stem cell transplantation - No evidence of graft-vs-host disease > grade II Hepatic - Bilirubin less than 3 times normal - AST less than 5 times normal Renal - Creatinine less than 2 times normal Other - Not pregnant - Fertile patients must use effective contraception - No concurrent severe infection - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 1 month since prior investigational therapy


NCT ID:

NCT00070226


Primary Contact:

Study Chair
Helen E. Heslop, MD
Baylor College of Medicine


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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