Hershey, Pennsylvania 17033

  • Lymphoma


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.


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



Primary Contact:

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

Backup Contact:


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: March 26, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.