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A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma

18 Years
Open (Enrolling)
Nasopharyngeal Carcinoma

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Trial Information

A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma

- 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

- 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

- 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

- 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.

Inclusion Criteria:

- Histologically or cytologically proven NPC of any WHO grade, associated with EBV
documented by the presence of EBER by in situ hybridization in the tumor. This must
be confirmed by pathology review at Brigham and Women's Hospital.

- Incurable NPC as defined by: relapsed or progressive disease after initial treatment
with no potentially curative option; NPC with metastasis

- Recovery from toxicity from any prior NPC therapy to grade 1 or better (CTCACE v.3.0)

- 18 years of age or older

- Evaluable disease, according to RECIST

- ECOG performance status of 0-1

- Adequate bone marrow, liver and renal function

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

- Acute hepatitis, known HIV, or other condition that requires immunosuppressive
therapy, including current use of systemic corticosteroids

- Autoimmune disease that is active and requires current therapy

- Active, uncontrolled, serious infection

- Incomplete healing from previous major surgery

- Significant history of uncontrolled cardiac disease

- Women who have a positive B-hCG test or are breastfeeding

- Any concurrent chemotherapy or other concurrent investigational agent not part of
this study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 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:

February 2007

Completion Date:

Related Keywords:

  • Nasopharyngeal Carcinoma
  • NPC
  • EPV
  • Carcinoma
  • Nasopharyngeal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115