Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma - Full Text View

Purpose

The purpose of this study is to determine the safety of making and giving Epstein-Barr virus (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the body. EBV immunotherapy product is made with white blood cells from the participants body that are collected intravenously. This EBV immunotherapy product may stop cancer cells from growing abnormally. EBV immunotherapy products have been used in several research studies for NPC. Information from these studies suggests the EBV immunotherapy products may stop the growth of NPC in some subjects.

Condition	Intervention
Nasopharyngeal Carcinoma	Biological: Epstein-Barr virus-specific adoptive T-cells immunotherapy

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Herpesvirus 4, Human

U.S. FDA Resources

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

Primary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The ability to collect specimens and measure potential biologic correlate of response to therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
time to progression in this patient population [ Time Frame: 2 years ] [ Designated as safety issue: No ]
median duration of response and median overall survival in this cohort of participants. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	February 2007
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously on Day 1 and Day 14

Detailed Description:

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 doctor.
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 tumor.
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 one.
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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431210

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Jochen Lorch, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Jochen Lorch, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00431210 History of Changes
Other Study ID Numbers:	06-179
Study First Received:	February 2, 2007
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

NPC
EPV

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 June 18, 2013