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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Jochen Lorch, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00834093
First received: February 2, 2009
Last updated: January 16, 2014
Last verified: January 2014
  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 2

Study Type: Interventional
Study Design: 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:


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: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General 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: NCT00834093     History of Changes
Other Study ID Numbers: 08-292, R21CA132279-01A1
Study First Received: February 2, 2009
Last Updated: January 16, 2014
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 August 27, 2014