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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006100
First Posted: January 27, 2003
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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
Lymphoma 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:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006100


Locations
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)
Investigators
Study Chair: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006100     History of Changes
Other Study ID Numbers: CDR0000068109
PSCI-2003-257
UAB-0002
NCI-G00-1829
First Submitted: August 3, 2000
First Posted: January 27, 2003
Last Update Posted: December 18, 2013
Last Verified: May 2005

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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Aldesleukin
Fludarabine phosphate
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs


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