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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.

Sponsors and Collaborators: Baylor College of Medicine
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
Drug: LMP2a-specific cytotoxic T-lymphocytes
Phase I

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Lymphoma   

U.S. FDA Resources

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

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
National Cancer Institute (NCI)

Investigators
Study Chair:     Helen E. Heslop, MD     Baylor College of Medicine    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000330143, BCM-H-9936
First Received:   October 3, 2003
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00070226
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  

Study placed in the following topic categories:
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Recurrence
Central nervous system lymphoma, primary
Virus Diseases
Lymphatic Diseases
Hodgkin lymphoma, childhood
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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