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

Phase 2
18 Years
Open (Enrolling)
Nasopharyngeal Carcinoma

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Trial Information

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jochen Lorch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

January 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Epstein-Barr Virus
  • NPC
  • EBV
  • immunotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617