Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
|ClinicalTrials.gov Identifier: NCT00431210|
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Biological: Epstein-Barr virus-specific adoptive T-cells immunotherapy||Phase 1|
- The first step in this research study is the peripheral blood collection. Approximately 60-90cc's will be collected intravenously and used to prepare the EBV immunotherapy product. It takes about 12 weeks to make the EBV immunotherapy product. During this time, the participant will receive standard of care as prescribed by their doctor.
- The EBV immunotherapy product will be made at a laboratory at the Connell & O'Reilly Families Cell and Manipulation Core Facility at the Dana-Farber Cancer Institute. The EBV immunotherapy product will contain T-cells that may react against your EBV-related tumor.
- A small amount of the EBV product will be used for research studies that will investigate components of the immune system that might be important in effective immunotherapy for NPC.
- EBV immunotherapy product will be given to the participant intravenously (infusion) on the first day of the research study. Fourteen days later, the participant will receive infusion #2. After infusion #2, the research doctor will do some tests to determine the effects that the EBV immunotherapy product has had on the tumor. If the research doctor thinks the participant will benefit from a third infusion then they may receive one.
- Before each infusion of EBV immunotherapy product, a physical examination and blood tests will be performed. During the active treatment phase of this research study, a physical exam and blood tests will be done every 1-2 weeks.
- Before each infusion of EBV immunotherapy product, the research doctor may do a fiberoptic exam of the participants nasopharynx by using a flexible scop to visualize the tumor.
- At 8 weeks post-infusion, we will evaluate the tumor by using a CT scan and/or MRI. We will also perform a PET or PET/CT scan if the research doctor feels it is necessary. We may do a chest CT scan to see if the tumor has spread to the lungs and an abdominal/pelvic CT scan or MRI if the participant has symptoms that suggesting that there may be tumor in the liver, or a bone scan to see if there is tumor in the bones.
- In addition to this study, the research doctor may ask permission to participate in optional research studies. We would like the participants permission to take a biopsy of the tumor after they have received infusion #2. The biopsy will be done by a surgeon who will review the risks of the procedure.
- The participant will return to the clinic for a follow-up visit where the response of the tumor will be evaluated, blood tests and a physical exam will be performed at the following intervals: for the first 2 months after the final infusion, every 2-4 weeks; for month 4 to month 12 after the final infusion, every 2 months; for the second year after the final infusion, every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||June 30, 2015|
|Actual Study Completion Date :||January 26, 2016|
Epstein-Barr virus-specific adoptive T-cells immunotherapy given intravenously on Days 1 and 14
Biological: Epstein-Barr virus-specific adoptive T-cells immunotherapy
Given intravenously on Day 1 and Day 14
- The feasibility and safety of generating and administrating and EBV-specific adoptive T cell in participants with incurable locoregional relapsed and/or distant metastatic EBV-associated NPC. [ Time Frame: 2 years ]
- The ability to collect specimens and measure potential biologic correlate of response to therapy [ Time Frame: 2 years ]
- time to progression in this patient population [ Time Frame: 2 years ]
- median duration of response and median overall survival in this cohort of participants. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431210
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute|