Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00002956
First received: November 1, 1999
Last updated: August 2, 2013
Last verified: November 2012
  Purpose

RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.

PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients [ Time Frame: baseline to x weeks post infusion ] [ Designated as safety issue: Yes ]
  • Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions. [ Time Frame: baseline to x weeks past infusion ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 1996
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infusions of EBV specific cytotoxic T lymphocytes
Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes

Detailed Description:

OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.

OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.

PROJECTED ACCRUAL: 10 patients will be accrued in this study.

  Eligibility

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

DISEASE CHARACTERISTICS: Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy, following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Patients serologically hepatitis B and C positive may receive cytotoxic T lymphocytes (CTL) from donors who are serologically positive for the same virus No hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present) Bilirubin less than 2.0 mg/dL Renal: No renal dysfunction Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac dysfunction Neurologic: No neurologic dysfunction Pulmonary: No pulmonary dysfunction Other: (patient) Must have an HLA identical or HLA haploidentical donor No patients developing EBV LPD who have a donor origin lymphoma Patients serologically positive for cytomegalovirus positive may receive CTL from donors who are serologically positive for the same virus (donor) Not HIV-1 positive Medically fit to undergo leukapheresis Donor CTL must be capable of lysing patient B lymphoblastoid cell line (BLCL) in vitro

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002956

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: Kenneth G. Lucas, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00002956     History of Changes
Other Study ID Numbers: CDR0000065433, UAB-9739, IUMC-9611-37, NCI-V97-1176
Study First Received: November 1, 1999
Last Updated: August 2, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
recurrent adult Hodgkin lymphoma
recurrent childhood lymphoblastic lymphoma
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
T-cell large granular lymphocyte leukemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Leukemia
Lymphoma
Lymphoproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 28, 2014