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T-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer, NPC

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Contents

Study summaryTimelineTable: Further ResourcesReferences
clinicaltrials.gov/study/NCT00609219
Is a
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Clinical study
1

Clinical Study attributes

NCT Number
NCT006092191
Health Conditions in Trial
Head and neck cancer
Head and neck cancer
1
Trial Recruitment Size
251
Trial Sponsor
Baylor College of Medicine
Baylor College of Medicine
1
Clinical Trial Start Date
2001
1
Primary Completion Date
2007
1
Study Completion Date
2012
1
Clinical Trial Study Type
Interventional1
Interventional Trial Purpose
Treatment1
Intervention Type
Biological1
Interventional Trial Phase
Phase 11
Participating Facility
Texas Children's Hospital
Texas Children's Hospital
1
Official Name
Administration of EBV-Specific T-Lymphocytes to Patients With EBV-Positive Nasopharyngeal Carcinoma1
Last Updated
October 10, 2012
1
Allocation Type
NA1
Intervention Model
Single Group Assignment1
Masking Type
None (Open Label)1

Other attributes

Intervention Treatment
autologous EBV specific CTLs1
Study summary

Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not gone away or is at high risk for coming back after treatment (including the best treatment we know for nasopharyngeal cancer). We are asking patients to volunteer to be in a research study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new experimental therapy. Most patients with nasopharyngeal cancer show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer, suggesting that it may play a role in causing this cancer. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells (called T cells) that have been trained to kill EBV-infected cells can survive in the patient's blood and affect the tumor. We have treated other patients with different EBV positive cancers and have had variable results. Some patients have had some response to the treatment. Some patients have been cured by the treatment. It is not possible for us to predict if this treatment will work for nasopharyngeal cancer. The purposes of this study are to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are, and to see whether this therapy might help patients with nasopharyngeal cancer.

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Further Resources

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