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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00834093
Recruitment Status : Active, not recruiting
First Posted : February 3, 2009
Last Update Posted : January 30, 2018
Brigham and Women's Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jochen Lorch, MD, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this research study is to determine how effective and how safe it is to give an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the participants body. The EBV immunotherapy product will be made with white blood cells from the participants blood and takes about 16 weeks to create. This EBV immunotherapy product may stop cancer cells from growing and cause the tumors to disappear.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Biological: Epstein-Barr Virus Specific Immunotherapy Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Study Start Date : January 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Biological/Vaccine
'Epstein-Barr Virus Specific Immunotherapy' given intravenously on Days 1 and 14
Biological: Epstein-Barr Virus Specific Immunotherapy
Two infusions given fourteen days apart, with a possible third infusion given 8 weeks later.
Other Name: Cell based vaccine

Primary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To estimate the one-year progression free survival, time to progression, median duration of response and overall survival with the EBV-specific immunotherapy [ Time Frame: 3 years ]
  2. To evaluate the safety of EBV-specific immunotherapy [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00834093

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Jochen Lorch, MD Dana-Farber Cancer Institute

Responsible Party: Jochen Lorch, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00834093     History of Changes
Other Study ID Numbers: 08-292
R21CA132279-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share IPD. Cumulative results will be posted and published.

Keywords provided by Jochen Lorch, MD, Dana-Farber Cancer Institute:
Epstein-Barr Virus

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Immunologic Factors
Physiological Effects of Drugs