Administration of Epstein Barr Virus - Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer (NPC-CTL)
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|ClinicalTrials.gov Identifier: NCT00706316|
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : July 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Cancer||Biological: EBV-Specific CTLs and CD45 Mab||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||November 2012|
Experimental: EBV-Specific CTLs and CD45 Mab
A dose escalation schema will be employed. Three to six patients will be treated at each of the following dose levels with EBV-Specific CTLs and CD45 Mab: Dose Level I: 2 x 10^7 cells/m2. Dose Level II: 5 x 10^7 cells/m2. Dose Level III: 1 x 10^8 cells/m2. Dose 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.
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
- To determine the safety of autologous EBV-specific CTLs in patients with nasopharyngeal cancer [ Time Frame: 24 months ]
- To obtain information on the expansion, persistence and anti-tumor effects of EBV-specific CTL lines in patients with nasopharyngeal cancer [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706316
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu, MD||University Health Network - Princess Margaret Hospital|