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Cytotoxic T Cells in Treating Patients With Relapsed Epstein-Barr Virus-Positive Lymphoma

This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), May 2008

Sponsors and Collaborators: Baylor College of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00675571
  Purpose

RATIONALE: White blood cells that have been treated in the laboratory may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cytotoxic T cells in treating patients with relapsed Epstein-Barr virus-positive lymphoma.


Condition Intervention Phase
Head and Neck Cancer
Lymphoma
Lymphoproliferative Disorder
Precancerous/Nonmalignant Condition
Small Intestine Cancer
Drug: TGF-B-resistant LMP-specific cytotoxic T-lymphocytes
Phase I

MedlinePlus related topics:   Cancer    Head and Neck Cancer    Intestinal Cancer    Lymphoma   

Drug Information available for:   Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   ADMINISTRATION OF TGF-B RESISTANT LMP-SPECIFIC CYTOTOXIC T-LYMPHOCYTES TO PATIENTS WITH RELAPSED EBV-POSITIVE LYMPHOMA

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

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Survival and immune function of TGFβ-resistant LMP-specific cytotoxic T-lymphocyte lines [ Designated as safety issue: No ]
  • Anti-viral and anti-tumor effects [ Designated as safety issue: No ]
  • Safety and response to extended dosage regimen [ Designated as safety issue: Yes ]

Estimated Enrollment:   18
Study Start Date:   April 2006
Estimated Primary Completion Date:   December 2025 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • To determine the safety of 2 intravenous injections of autologous or allogeneic TGFβ-resistant LMP-specific cytotoxic T-lymphocytes (CTL) in patients with relapsed Hodgkin or non-Hodgkin lymphoma.
  • To determine the survival and the immune function of TGFβ-resistant LMP-specific cytotoxic T-lymphocyte lines.
  • To assess the anti-viral and anti-tumor effects of TGFβ-resistant LMP-specific CTL.
  • To obtain preliminary information on the safety and response to an extended dosage regimen.

OUTLINE: Peripheral blood are collected from the patient or donor for generation of TGFβ-resistant LMP-specific cytotoxic T lymphocytes (CTLs).

Patients receive TGFβ-resistant LMP-specific CTLs over 1-10 minutes on days 0 and 14.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for up to 10 years.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of any of the following:

    • Epstein-Barr Virus (EBV)-positive lymphoma
    • EBV (associated)-T/NK-lymphoproliferative disease
    • Lymphoepithelioma regardless of the histological subtype
  • In second or subsequent relapse, including after autologous or syngeneic stem cell transplantation (SCT) OR patients with detectable/relapsed disease after allogeneic SCT
  • Diagnosis confirmed on a relapse biopsy sample
  • Tumor tissue EBV positive
  • If post allogeneic SCT, must have ≥ 50% donor chimerism in either peripheral blood or bone marrow
  • No evidence of GVHD > grade II at time of enrollment

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 50-100%
  • Life expectancy ≥ 6 weeks
  • No severe intercurrent infection
  • HIV negative at time of procurement cells for cytotoxic T lymphocytes (CTL) generation
  • Bilirubin ≤ 3 times normal
  • AST≤ 5 times normal
  • Hemoglobin > 8.0 g/dL
  • Creatinine ≤ 2 times normal for age
  • Oxygen saturations > 93% on room air (measured by pulse oximetry)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • More than 1 month since prior investigational agent
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675571

Sponsors and Collaborators
Baylor College of Medicine
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Catherine Bollard     Baylor College of Medicine    
Principal Investigator:     Helen E. Heslop, MD     Baylor College of Medicine    
Principal Investigator:     Cliona Rooney, PhD     Baylor College of Medicine    
  More Information


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

Study ID Numbers:   CDR0000595465, BCM-17946, BCM-TGFB
First Received:   May 8, 2008
Last Updated:   October 16, 2008
ClinicalTrials.gov Identifier:   NCT00675571
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Burkitt lymphoma  
recurrent adult diffuse large cell lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
recurrent adult grade III lymphomatoid granulomatosis  
recurrent adult Hodgkin lymphoma  
recurrent adult immunoblastic large cell lymphoma  
recurrent adult lymphoblastic lymphoma  
recurrent adult T-cell leukemia/lymphoma  
recurrent childhood grade III lymphomatoid granulomatosis  
recurrent childhood large cell lymphoma  
recurrent childhood lymphoblastic lymphoma  
recurrent childhood small noncleaved cell lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
recurrent/refractory childhood Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent mycosis fungoides/Sezary syndrome
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
Waldenstrom macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Sezary syndrome
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Lymphomatoid granulomatosis
Mycoses
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Virus Diseases
Waldenstrom Macroglobulinemia
Hodgkin lymphoma, childhood
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Hodgkin's disease
Precancerous Conditions
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Sodium Salicylate

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

ClinicalTrials.gov processed this record on October 23, 2008




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