LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA)

Completed · Phase 1

Conditions studied: Nasopharyngeal Carcinoma

In brief

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 investigational product not approved by the Food and Drug Administration.

Key facts

Study ID: NCT00516087
Run by: Baylor College of Medicine
People needed: 23
Starts: 2007-08-01
Expected to finish: 2013-07-01
Last updated by the study team: 2017-02-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients with NPC in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive disease) in whom the EBV genome or antigens have been demonstrated in tissue biopsies will be eligible for this trial.
Any patient with EBV positive NPC, in relapse or with primary resistant disease
Patients with a life expectancy 6 weeks or greater
Patients with bilirubin less than 2x normal, SGOT less than 3x normal, and Hgb more than 8.0.
Patients with a Karnofsky score (age greater than/=16) of or Lansky score (age less than 16) of greater than/= 50
Patients with a creatinine 2x normal for age or less
Patients should have been off other investigational therapy for one month prior to entry in this study
Patient, parent/guardian able to give informed consent

You may not qualify if…

Severe intercurrent infection
Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.

Where it is running

Houston Methodist Hospital — Houston, Texas, United States
Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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