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Biological Therapy in Treating Patients With Lymphoma or Lymphoproliferative Disease

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002663
  Purpose

RATIONALE: Some types of lymphoma or lymphoproliferative disease are associated with Epstein-Barr virus. White blood cells from donors who are immune to Epstein-Barr virus may be an effective treatment for those cancers.

PURPOSE: This phase I/II trial is studying the side effects and best dose of biological therapy in treating patients with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Phase I
Phase II

MedlinePlus related topics:   Cancer    Fungal Infections    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases

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

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Potential of adoptive immunotherapy [ Designated as safety issue: No ]
  • In vivo biodistribution, expansion, and duration of engraftment [ Designated as safety issue: No ]
  • Incidence, kinetics, and durability of pathological and/or clinical responses [ Designated as safety issue: No ]

Estimated Enrollment:   18
Study Start Date:   March 1995
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the toxicity and therapeutic potential of adoptive immunotherapy with Epstein Barr virus (EBV) specific cytotoxic T lymphocytes derived from HLA-histocompatible related donors in the treatment of patients with EBV-induced lymphomas and other lymphoproliferative diseases in immunocompromised hosts.
  • Evaluate in vivo biodistribution, expansion, and duration of engraftment of successive doses of EBV-reactive lymphocytes within immunocompromised histocompatible hosts with EBV-associated lymphoproliferative diseases, and correlate these findings with the patients' T-cell populations, general immune status, and capacity to generate allospecific antidonor response.
  • Determine incidence, kinetics, and durability of pathologic and/or clinical responses in this patient population treatment with infusions of these EBV-specific T cells.

OUTLINE: This is a dose escalation study. Patients are stratified according to graft vs host disease risk (high vs low).

Patients receive adoptive immunotherapy with allogeneic Epstein Barr virus (EBV) specific cytotoxic T lymphocytes IV on days 1, 8, and 15. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

The dose of allogeneic EBV specific cytotoxic T lymphocytes is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed every 2 weeks for 6 months, every 2 months for 2 years, and then every 4 months until disease progression.

PROJECTED ACCRUAL: Approximately 3-18 patients per stratum will be accrued for this study within 1-2 years.

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

Criteria

DISEASE CHARACTERISTICS:

  • Pathologically documented Epstein-Barr virus (EBV)-positive lymphoma or other lymphoproliferative disease
  • Immunocompromised as a consequence of:

    • Genetic or acquired immunodeficiency (including AIDS)
    • Allogeneic bone marrow or organ transplant
  • Normal lymphocyte donor related to patient or, for organ allografts, to organ:

    • Immunocompetent
    • HLA compatible
    • EBV seropositive
    • HIV negative
    • Organ donors at least HLA haplotype-identical with the lymphoma

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • No moribund patients

Life expectancy:

  • At least 9 weeks

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Pregnant women eligible

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002663

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center     Recruiting
      New York, New York, United States, 10021
      Contact: Esperanza B. Papadopoulos, MD     212-639-8276     papadope@mskcc.org    

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center

Investigators
Study Chair:     Richard J. O'Reilly, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000064247, MSKCC-95024, NCI-V95-0685
First Received:   November 1, 1999
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00002663
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma  
stage II adult Hodgkin lymphoma  
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  
stage I cutaneous T-cell non-Hodgkin lymphoma  
stage II cutaneous T-cell non-Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
Burkitt lymphoma  
stage I childhood lymphoblastic lymphoma  
stage II childhood lymphoblastic lymphoma  
stage III childhood lymphoblastic lymphoma  
stage IV childhood lymphoblastic lymphoma  
recurrent childhood lymphoblastic lymphoma
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
stage II childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Hodgkin's disease
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Mycoses
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Hodgkin Disease
Lymphoma
Large granular lymphocyte leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Acquired Immunodeficiency Syndrome
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence

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

ClinicalTrials.gov processed this record on September 16, 2008




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