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

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Brigham and Women's Hospital Massachusetts General Hospital National Cancer Institute (NCI)
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00834093

Purpose

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	Intervention	Phase
Nasopharyngeal Carcinoma	Biological: Epstein-Barr Virus Specific Immunotherapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To evaluate the safety of EBV-specific immunotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Two infusions given fourteen days apart, with a possible third infusion given 8 weeks later.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834093

Contacts

Contact: Marshall Posner, MD

617-632-3090

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Marshall Posner, MD 617-632-3090 marshall_posner@dfci.harvard.edu
Principal Investigator: Marshall Posner, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Lori J Wirth, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Marshall Posner, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Marshall R. Posner, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00834093 History of Changes
Other Study ID Numbers:	08-292, R21 CA132279-01A1
Study First Received:	February 2, 2009
Last Updated:	October 30, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Epstein-Barr Virus
NPC
EBV
immunotherapy

Additional relevant MeSH terms:

Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012