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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 3, 2000
Last updated: December 17, 2013
Last verified: May 2005

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.

Condition Intervention Phase
Biological: aldesleukin
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 75

Performance status:

  • Not specified

Life expectancy:

  • At least 8 weeks


  • Not specified


  • 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


  • Creatinine clearance greater than 50 mL/min
  • No renal dysfunction causing moribundity


  • No cardiac dysfunction causing moribundity


  • No pulmonary dysfunction causing moribundity


  • No neurologic dysfunction causing moribundity
  • No history of severe transfusion reactions with blood products (including fetal calf serum)
  • Not pregnant


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • No concurrent antimetabolites

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00006100

United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Cancer Institute (NCI)
Study Chair: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
  More Information

Additional Information:
Publications: Identifier: NCT00006100     History of Changes
Other Study ID Numbers: CDR0000068109, PSCI-2003-257, UAB-0002, NCI-G00-1829
Study First Received: August 3, 2000
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Fludarabine phosphate
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 08, 2015