A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT00834093|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2009
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Biological: Epstein-Barr Virus Specific Immunotherapy||Phase 2|
Subjects will register and provide a blood sample which will be used to create the immune therapy product. This will take about 16 weeks during which time they will receive chemotherapy for their nasopharynx cancer. When the immune product is ready the chemotherapy will be stopped and the immunotherapy product will be given to the participant by infusion. On the first day of the research treatment, participants will receive infusion #1 of the EBV immunotherapy product. Fourteen days later, the participant will receive infusion #2. Eight weeks after infusion #2, the research doctor will do some tests to determine the effects that the EBV immunotherapy product has had on the participants tumor. If the research doctor thinks that they would benefit from a third infusion of the EBV immunotherapy product and there is sufficient immunotherapy product remaining, the participant my be given infusion #3.
- Before each infusion of the EBV immunotherapy product participants will have a physical exam, blood work and fiberoptic exam of the nasopharynx if needed.
- Within 28 days of receiving the EBV immunotherapy product for the first time, we will evaluate the participants tumor by using CT scan and/or MRI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||October 2019|
'Epstein-Barr Virus Specific Immunotherapy' given intravenously on Days 1 and 14
Biological: Epstein-Barr Virus Specific Immunotherapy
Two infusions given fourteen days apart, with a possible third infusion given 8 weeks later.
Other Name: Cell based vaccine
- To determine the overall response rate (ORR) with 90% confidence intervals (CIs) of EBV-specific immunotherapy in patients with recurrent and/or metastatic EBV-associated NPC using modified RECIST [ Time Frame: 3 years ]
- To estimate the one-year progression free survival, time to progression, median duration of response and overall survival with the EBV-specific immunotherapy [ Time Frame: 3 years ]
- To evaluate the safety of EBV-specific immunotherapy [ Time Frame: 3 years ]
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): NCT00834093
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute|