Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma

Milton S. Hershey Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lymphoma

Interventions

aldesleukinBIOLOGICAL

allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytesBIOLOGICAL

fludarabine phosphateDRUG

peripheral blood stem cell transplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Data from ClinicalTrials.gov

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