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| Sponsors and Collaborators: |
Baylor College of Medicine National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070226 |
Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's or donor's a cytotoxic 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 autologous or donor cytotoxic T-lymphocytes in treating patients with relapsed Epstein-Barr virus-associated Hodgkin's lymphoma or non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: LMP2a-specific cytotoxic T-lymphocytes |
Phase I |
| MedlinePlus related topics: | Cancer Hodgkin's Disease Lymphoma |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Administration of LMP2A-Specific Cytotoxic T Cells to Patients With Relapsed EBV Positive Lymphoma |
| Estimated Enrollment: | 18 |
| Study Start Date: | July 2003 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Peripheral blood is collected from the patient or a donor and allogeneic or autologous dendritic cells (DC) are generated over 7 days using sargramostim (GM-CSF) and interleukin-4 (IL-4). DC are transduced with recombinant AdLMP2A and matured with GM-CSF, TNFa, PGE-1, and IL-4 over 2 days to stimulate cytotoxic T-lymphocytes (CTL). Patients receive LMP2A-specific CTL IV over 1-10 minutes on days 0 and 14.
Cohorts of 3-6 patients receive escalating doses of LMP2A-specific CTL.
Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of LMP2A-specific CTL IV over 1-10 minutes once monthly.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma
Meets criteria for 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Texas | |||||
| Dan L. Duncan Cancer Center at Baylor College of Medicine | |||||
| Houston, Texas, United States, 77030 | |||||
| Baylor College of Medicine |
| National Cancer Institute (NCI) |
| Study Chair: | Helen E. Heslop, MD | Baylor College of Medicine |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000330143, BCM-H-9936 |
| First Received: | October 3, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00070226 |
| Health Authority: | United States: Federal Government |
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