Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments aldesleukin, allogeneic epstein-barr virus-specific cytotoxic t lymphocytes, fludarabine phosphate, peripheral blood stem cell transplantation
Phase phase 1
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).