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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: aldesleukin
* Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
* Drug: fludarabine phosphate
* Procedure: peripheral blood stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|nan|
|Drug: fludarabine phosphate|nan|
|Procedure: peripheral blood stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult Hodgkin lymphoma