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NCT00516087 · ClinicalTrials.gov registry record · Phase 1
LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA)
A Phase 1 study of Nasopharyngeal Carcinoma, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 2
- Study locations
NCT00516087 is a Phase 1 study of Nasopharyngeal Carcinoma that has completed, run by Baylor College of Medicine. The registered enrollment target is 23 participants, below the 97-participant average among 7 other Nasopharyngeal Carcinoma trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00516087, a Phase 1 study of Nasopharyngeal Carcinoma, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients have a type of cancer called nasopharyngeal carcinoma (NPC) which has either come back, not gone away or is at high risk for coming back after the best treatment we know for this disease. We are inviting patients to participate in a research study using a new experimental therapy consisting of special immune system cells called LMP1- and LMP2-specific cytotoxic T lymphocytes (LMP1- and LMP2-CTLs). Some patients with nasopharyngeal carcinoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC, suggesting that it may play a role in causing the disease. 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 recognize and kill special parts of EBV infected cells can survive in blood and affect the tumor. We have used this sort of therapy to treat a different type of cancer that occurs after bone marrow and solid organ transplant called post-transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. We grew T cells in the laboratory that recognized all 9 proteins and were able to prevent and treat post-transplant lymphoma. However nasopharyngeal carcinoma tumor cells only express 2 EBV proteins (LMP1 and LMP2) on their surfaces. In a previous study we made T cells that recognized all 9 proteins and gave them to patients with NPC. While some patients had a response, only a few patients had their cancer completely go away. We are now trying to find out if we can improve this treatment by growing and giving T cells where more of the cells will recognize two of the proteins expressed on NPC cells called LMP1 and LMP2. These special T cells are called LMP1- and LMP2-CTLs. These LMP1- and LMP2-CTLs are an investigat
Conditions Studied
Interventions
- BIOLOGICAL Genetically modified CTLs
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00516087
The ClinicalTrials.gov registry entry for NCT00516087 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 7 other Nasopharyngeal Carcinoma trials with a reported enrollment target (76% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nasopharyngeal Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Genetically modified CTLs is the first listed.
NCT00516087 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00516087 about?
NCT00516087 is a clinical study titled "LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA)". Patients have a type of cancer called nasopharyngeal carcinoma (NPC) which has either come back, not gone away or is at high risk for coming back after the best treatment we know for this disease. We are inviting patients to participate in a research study using a new experimental therapy consisting...
What is the current status of trial NCT00516087?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2007-08. Estimated completion is 2013-07.
What conditions does trial NCT00516087 study?
This clinical trial studies the following conditions: Nasopharyngeal Carcinoma.
What interventions are being tested in trial NCT00516087?
The interventions under investigation include: Genetically modified CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00516087?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00516087 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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