Full Text View
Tabular View
No Study Results Posted
Related Studies
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.
Study NCT00070226   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes

October 3, 2003
February 6, 2009
July 2003
December 2009   (final data collection date for primary outcome measure)
Safety at 6 weeks [ Designated as safety issue: Yes ]
Safety at 6 weeks
Complete list of historical versions of study NCT00070226 on ClinicalTrials.gov Archive Site
Disease response at 8 weeks [ Designated as safety issue: No ]
Disease response at 8 weeks
 
Autologous or Donor Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Administration of LMP2A-Specific Cytotoxic T Cells to Patients With Relapsed EBV Positive Lymphoma

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.

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.

Phase I
Interventional
Treatment, Open Label
  • Lymphoma
  • Lymphoproliferative Disorder
Biological: LMP2a-specific cytotoxic T-lymphocytes
 
Bollard CM, Gottschalk S, Leen AM, Weiss H, Straathof KC, Carrum G, Khalil M, Wu MF, Huls MH, Chang CC, Gresik MV, Gee AP, Brenner MK, Rooney CM, Heslop HE. Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood. 2007 Oct 15;110(8):2838-45. Epub 2007 Jul 3.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
18
 
December 2009   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00070226
 
CDR0000330143, BCM-H-9936
Baylor College of Medicine
National Cancer Institute (NCI)
Study Chair: Helen E. Heslop, MD Baylor College of Medicine
National Cancer Institute (NCI)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP