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| Sponsored by: |
Baylor College of Medicine |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00671164 |
Purpose
RATIONALE: Treating a person's or donor's T-lymphocytes in the laboratory and reinfusing them may cause a stronger immune response to kill Epstein-Barr virus-associated cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of T-lymphocytes in treating patients with Epstein-Barr virus-positive lymphoma, lymphoepithelioma, or severe chronic Epstein-Barr virus infection syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Lymphoma Lymphoproliferative Disorder Precancerous/Nonmalignant Condition Small Intestine Cancer |
Biological: allogeneic LMP1-/LMP2- specific cytotoxic T-lymphocytes Biological: autologous LMP1-/LMP2- specific cytotoxic T-lymphocytes |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma |
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according disease status (relapsed lymphoma/lymphoepithelioma or at high risk for relapse vs in remission or has minimal residual disease after autologous or syngeneic stem cell transplantation vs in remission or has detectable disease after allogeneic stem cell transplantation).
Peripheral blood mononuclear cells (PBMC) are collected from the patient or a donor for generation of LMP-specific cytotoxic T-lymphocytes (CTL). PBMC are stimulated with antigen-presenting cells (APC) expressing LMP1/2 antigen and expanded with aldesleukin.
Patients receive autologous or allogeneic LMP-specific CTLs IV over 1-10 minutes on days 0 and 14. Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of CTLs once a month.
After completion of study treatment, patients are followed at 3, 6, 9, and 12 months and then annually for 5 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of any of the following:
Severe chronic active EBV infection syndrome (SCAEBV)
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
| Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Vicky Torrano 832-824-7821 | |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Vicky Torrano 832-824-7821 | |
| Principal Investigator: | Catherine Bollard | Baylor College of Medicine |
| Principal Investigator: | Helen E. Heslop, MD | Baylor College of Medicine |
More Information
| Study ID Numbers: | CDR0000595213, BCM-H-9936-ALCI |
| Study First Received: | May 2, 2008 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00671164 History of Changes |
| Health Authority: | Unspecified |
|
Epstein-Barr virus infection post-transplant lymphoproliferative disorder recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma stage I adult Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II adult Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III adult Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV childhood Hodgkin lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma adult grade III lymphomatoid granulomatosis |
recurrent adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma contiguous stage II adult Burkitt lymphoma noncontiguous stage II adult Burkitt lymphoma recurrent adult Burkitt lymphoma stage I adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma |
|
Precancerous Conditions Hodgkin Lymphoma, Childhood Gastrointestinal Diseases Central Nervous System Lymphoma, Primary Ileal Diseases Epstein Barr Virus, Chronic Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Duodenal Neoplasms Ileal Neoplasms Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Epstein-Barr Virus Infections Lymphoma, Large-cell |
Hodgkin Disease Lymphoma Duodenal Diseases Jejunal Neoplasms Lymphomatoid Granulomatosis Lymphoma, Large B-Cell, Diffuse Digestive System Neoplasms Immunoproliferative Disorders Hodgkin Lymphoma, Adult Immunoblastic Lymphadenopathy Hodgkin's Disease Small Non-cleaved Cell Lymphoma Intestinal Diseases Recurrence Intestinal Neoplasms |
|
Precancerous Conditions Gastrointestinal Diseases Tumor Virus Infections Ileal Diseases Neoplasms, Experimental Duodenal Neoplasms Neoplasms by Site Ileal Neoplasms Jejunal Diseases Lymphoma, Large-Cell, Immunoblastic Epstein-Barr Virus Infections Lymphoma Duodenal Diseases Jejunal Neoplasms Neoplasms by Histologic Type |
Immunoproliferative Disorders Digestive System Neoplasms Immune System Diseases Intestinal Diseases Intestinal Neoplasms Herpesviridae Infections Virus Diseases Lymphatic Diseases Neoplasms Digestive System Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms DNA Virus Infections Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |