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Sponsored by: |
Baylor College of Medicine |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00608309 |
RATIONALE: Donor T lymphocytes that have been treated with the Epstein-Barr virus may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best way to give T lymphocytes in treating patients undergoing a donor bone marrow transplant.
Condition | Intervention | Phase |
Cancer |
Drug: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes Procedure: adjuvant therapy Procedure: immunological diagnostic method Procedure: polymerase chain reaction |
Phase I |
Genetics Home Reference related topics: | ataxia-telangiectasia breast cancer Friedreich ataxia |
MedlinePlus related topics: | Bone Marrow Transplantation Breast Cancer Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Administration of EBV Specific Cytotoxic T Lymphocytes to Recipients of Mismatched-Related or Phenotypically Similar Unrelated Donor Marrow Grafts |
Estimated Enrollment: | 20 |
Study Start Date: | May 1993 |
Estimated Primary Completion Date: | December 2022 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive an infusion of Epstein-Barr Virus (EBV)-specific T cells on or after day 45 of an allogeneic stem cell transplantation regimen. EBV DNA persistence in peripheral blood is monitored by polymerase chain reaction before and after the infusion. Patients with EBV DNA levels above 1000 copies/μg or with persistent disease may receive up to 5 additional infusions of cytotoxic T lymphocytes (CTLs). Treatment repeats every 6 weeks in the absence of unacceptable toxicity.
Patients undergo blood sample collection periodically for immunophenotyping and tetramer analysis, assessment of EBV DNA content, and for reactivation of EBV-specific CTL lines to analyze specificity.
After completion of study treatment, patients are followed weekly for 6 weeks and then every 3 months for up to 1 year.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Receiving a matched sibling transplantation or T-replete transplantation AND meets the following criteria:
At high risk of developing Epstein-Barr virus lymphoproliferative disease (EBV LPD) due to 1 of the following conditions:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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: Diana Cooper-Havlik 832-824-4594 | |||||
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting | ||||
Houston, Texas, United States, 77030-2399 | |||||
Contact: Diana Cooper-Havlik 832-824-4594 dxcooper@txccc.org |
Baylor College of Medicine |
Principal Investigator: | Helen E. Heslop, MD | Baylor College of Medicine |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000582813, BCM-H-6676, BCM-ETNA |
First Received: | February 1, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00608309 |
Health Authority: | Unspecified |
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