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Autologous or Donor Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Baylor College of Medicine
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070226
  Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's or donor's a cytotoxic T lymphocytes in the laboratory and reinfusing them may cause a stronger immune response to kill Epstein-Barr virus-associated cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of autologous or donor cytotoxic T-lymphocytes in treating patients with relapsed Epstein-Barr virus-associated Hodgkin's lymphoma or non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Lymphoproliferative Disorder
Biological: LMP2a-specific cytotoxic T-lymphocytes
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Administration of LMP2A-Specific Cytotoxic T Cells to Patients With Relapsed EBV Positive Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety at 6 weeks [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease response at 8 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: July 2003
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety of autologous or allogeneic LMP2A-specific cytotoxic T-lymphocytes in patients with relapsed Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma.
  • Determine the survival and immune function of patients treated with this regimen.
  • Determine the antiviral and antitumor effects of this regimen in these patients.
  • Obtain preliminary information on the safety of and response to an extended dosage of this regimen in these patients.

OUTLINE: Peripheral blood is collected from the patient or a donor and allogeneic or autologous dendritic cells (DC) are generated over 7 days using sargramostim (GM-CSF) and interleukin-4 (IL-4). DC are transduced with recombinant AdLMP2A and matured with GM-CSF, TNFa, PGE-1, and IL-4 over 2 days to stimulate cytotoxic T-lymphocytes (CTL). Patients receive LMP2A-specific CTL IV over 1-10 minutes on days 0 and 14.

Cohorts of 3-6 patients receive escalating doses of LMP2A-specific CTL.

Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of LMP2A-specific CTL IV over 1-10 minutes once monthly.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma

    • Any histological subtype
    • Meets criteria for 1 of the following:

      • Second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy is contraindicated (e.g., patients who develop Hodgkin's lymphoma after a prior solid organ transplant, who have lymphoma as a second malignancy, or who have relapsed multiple times AND at high risk of relapse) (group A)
      • In remission OR with minimal residual disease after autologous stem cell transplantation for Hodgkin's or non-Hodgkin's lymphoma or lymphoepithelioma (group B)
      • In remission OR with detectable disease after allogeneic stem cell transplantation (group C)

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Karnofsky 50-100%

Life expectancy

  • At least 6 weeks

Hematopoietic

  • Hemoglobin greater than 8.0 g/dL
  • More than 50% donor chimerism in either peripheral blood or bone marrow after allogeneic stem cell transplantation
  • No evidence of graft-vs-host disease > grade II

Hepatic

  • Bilirubin less than 3 times normal
  • AST less than 5 times normal

Renal

  • Creatinine less than 2 times normal

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • No concurrent severe infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 1 month since prior investigational therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070226

Locations
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Study Chair: Helen E. Heslop, MD Baylor College of Medicine
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000330143, BCM-H-9936
Study First Received: October 3, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00070226     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
primary central nervous system lymphoma
post-transplant lymphoproliferative disorder

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Pathologic Processes
Disease
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on November 09, 2009