A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma

Inclusion Criteria

• Histologically or cytologically proven NPC of an WHO grade, associated with EBV infection documented by the presence of EBER expression by in situ hybridization in the tumor. Positive EBER staining from another institution must be confirmed by pathology review at Brigham and Women's Hospital. Other confirmation of EBV-associated disease is acceptable, such as EBV DNA in situ hybridization, if EBER analysis is not adequate
• Incurable NPC
• Recovery from toxicity from any prior NPC therapy to grade 1 or better
• 18 years of age or older
• Evaluable or measurable disease, according to modified RECIST
• ECOG Performance Status of 0 or 1
• Adequate bone marrow, liver and renal function as outlined in protocol

Exclusion Criteria

• Radiotherapy for primary NPC within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks
• Chemotherapy for NPC within 2 weeks of enrollment
• Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
• Uncontrolled central nervous system metastases
• Active hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids
• Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
• Active uncontrolled serious infection
• Women of child-bearing potential who have a positive pregnancy test or are breast-feeding