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

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

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
Study First Received:	May 8, 2008
Last Updated:	December 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
Ileal Diseases
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Lymphomatoid granulomatosis
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases
Jejunal Diseases

ClinicalTrials.gov processed this record on January 16, 2009