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Sponsors and Collaborators: |
Baylor College of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00675571 |
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 |
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Head and Neck Cancer Lymphoma Lymphoproliferative Disorder Precancerous/Nonmalignant Condition Small Intestine Cancer |
Biological: TGF-beta-resistant LMP-specific cytotoxic T-lymphocytes |
Phase I |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | December 2025 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study ID Numbers: | CDR0000595465, BCM-17946, BCM-TGFB |
Study First Received: | May 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00675571 History of Changes |
Health Authority: | Unspecified |
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 |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms Virus Diseases Waldenstrom Macroglobulinemia B-cell Lymphomas |
Leukemia, T-Cell Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Precancerous Conditions Gastrointestinal Diseases Hodgkin Lymphoma, Childhood Lymphoma, Follicular Central Nervous System Lymphoma, Primary Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell |
Jejunal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Precancerous Conditions Gastrointestinal Diseases Intestinal Diseases Ileal Diseases Intestinal Neoplasms Duodenal Neoplasms |
Lymphatic Diseases Neoplasms Digestive System Diseases Neoplasms by Site Ileal Neoplasms Jejunal Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Lymphoproliferative Disorders Lymphoma Duodenal Diseases |