Expired Study
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Hershey, Pennsylvania 17033


Purpose:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma. PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive, relapsed, or refractory Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the toxicity of allogeneic Epstein Barr virus (EBV)-specific cytotoxic T-lymphocytes (EBV CTL) in patients with progressive, relapsed, or refractory EBV-positive Hodgkin's lymphoma. - Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL. OUTLINE: Donors undergo leukapheresis. Epstein Barr virus-specific cytotoxic T lymphocytes (EBV CTL) are cultured in vitro. Patients receive an infusion of EBV CTL over 10 minutes on day 0. The EBV CTL infusion is preceded by 3 doses of fludarabine. Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion. Patients are followed weekly for 1.5 months, twice a month for 1.5 months, and then monthly for 3 months. PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven Hodgkin's lymphoma - Progressive, relapsed, or refractory disease after prior chemotherapy, radiotherapy, and/or stem cell transplantation - Epstein Barr virus (EBV) positive by immunohistochemical staining for LMP-1 or 2 OR the presence of EBV RNA (EBER) - Availability of an HLA identical or haploidentical donor for cytotoxic T-lymphocytes, meeting the following criteria: - EBV seropositive - HIV negative - HTLV-1 negative - Hepatitis B surface antigen and hepatitis B core antibody IgM negative - Hepatitis C antibody negative - Must share at least 1 HLA haplotype with donor PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - Not specified Life expectancy: - At least 8 weeks Hematopoietic: - Not specified Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT/SGPT less than 2.5 times normal (unless liver metastases are present) - If there is liver involvement by disease, an obvious relationship between SGOT/SGPT and disease activity is required - No hepatic dysfunction causing moribundity Renal: - Creatinine clearance greater than 50 mL/min - No renal dysfunction causing moribundity Cardiovascular: - No cardiac dysfunction causing moribundity Pulmonary: - No pulmonary dysfunction causing moribundity Other: - No neurologic dysfunction causing moribundity - No history of severe transfusion reactions with blood products (including fetal calf serum) - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - No concurrent antimetabolites Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - Not specified


NCT ID:

NCT00006100


Primary Contact:

Study Chair
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center


Backup Contact:

N/A


Location Contact:

Hershey, Pennsylvania 17033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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