Administration of Epstein Barr Virus - Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer — NPC-CTL  

Nasopharyngeal Cancer Clinical Trial

Official title: A Phase I Trial Evaluating the Administration of Epstein Barr Virus (EBV)-Specific Cytotoxic T-Lymphocytes (CTLs) to Patients With Recurrent or Metastatic EBV-Positive Nasopharygneal Cancer (NPC)

Status Completed

Clinical Trial Summary

Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or spreads to other organs, treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the development of NPC, and studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.

Clinical Trial Description

Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy. However, the treatment of this cancer can lead to later complications, including other cancers, and if NPC relapses or spreads to other organs, the treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs.

Epstein-Barr Virus (EBV) is known to play a role in the development of NPC in individuals, especially those with a compromised immune system. Studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nasopharyngeal Cancer

• NCT number: NCT00706316
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Completed
• Phase: Phase 1
• Start date: December 2007
• Completion date: November 2012