A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Jochen Lorch, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|