Autologous or Donor Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma - Full Text View

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:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

U.S. FDA Resources

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

Additional Information:

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

Publications:

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.

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