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Spots Global Cancer Trial Database for Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma

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Trial Identification

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

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

Study ID: NCT00006100

Conditions

Lymphoma

Study Description

Brief Summary: 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: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Contact Details

Name: Kenneth G. Lucas, MD

Affiliation: Milton S. Hershey Medical Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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