Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma
This trial is active, not recruiting.
|Treatments||aldesleukin, allogeneic epstein-barr virus-specific cytotoxic t lymphocytes, fludarabine phosphate, peripheral blood stem cell transplantation|
|Sponsor||Milton S. Hershey Medical Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2000|
|Trial identifier||NCT00006100, CDR0000068109, NCI-G00-1829, PSCI-2003-257, UAB-0002|
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.
Male or female participants from 18 years up to 75 years old.
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
|Official title||A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease|
|Description||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.|
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