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

NCT00706316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-07-10

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Cancer

Interventions

BIOLOGICAL

EBV-Specific CTLs and CD45 Mab

One time infusion (IV) at one of the following dose levels: Dose level I: 5 x 107 cells/m2 Dose level II: 1 x 108 cells/m2 Dose level III: 2 x 108 cells/m2

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Lillian Siu, MD · University Health Network - Princess Margaret Hospital

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-08-31
Completion
2012-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00706316 on ClinicalTrials.gov