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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00706316 |
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 cytototoxic 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.
Condition | Intervention | Phase |
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Nasopharyngeal Cancer |
Biological: EBV-Specific CTLs and CD45 Mab |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Active Control, Single Group Assignment, Safety Study |
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) |
Estimated Enrollment: | 25 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
A dose escalation schema will be employed. Three to six patients will be treated at each of the following dose levels:Dose Level I: 2 x 10^7 cells/m2Dose Level II: 5 x 10^7 cells/m2Dose Level III: 1 x 10^8 cells/m2Dose escalation decisions will be made after review of the data from the current dose level. There will be no intra-patient escalation. An additional 6-10 patients with measurable disease will be treated at the recommended phase II dose to expand the experience at this dose level.
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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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with:
All patients must have measurable disease, with minimum indicator lesions size as follows:
Exclusion Criteria:
Contact: Lillian Siu | 416 946 2911 | lillian.siu@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Lillian Siu 416 946 2911 lillian.siu@uhn.on.ca | |
Principal Investigator: Lillian Siu, MD | |
Principal Investigator: Armand Keating, MD |
Principal Investigator: | Lillian Siu, MD | University Health Network - Princess Margaret Hospital |
Responsible Party: | University Health Network, Princess Margaret Hospital ( Dr. Lillian Siu ) |
Study ID Numbers: | NPC-CTL, OCRN #03-NOV-0422 |
Study First Received: | June 25, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00706316 |
Health Authority: | Canada: Health Canada |
Nasopharygneal Cancer Epstein Barr Virus (EBV)-Specific Cytotoxic T-Lymphocytes |
Recurrent Metastatic EBV-Positive Nasopharygneal Cancer |
Virus Diseases Nasopharyngeal carcinoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Head and Neck Neoplasms |
Pharyngeal Neoplasms Stomatognathic Diseases Pharyngeal Diseases Nasopharyngeal Neoplasms Recurrence |
Neoplasms Neoplasms by Site Nasopharyngeal Diseases |