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

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Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III 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Brief Title

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

Official Title

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

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.

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 To estimate the one-year progression free survival, time to progression, median duration of response and overall survival with the EBV-specific immunotherapy

Condition

Nasopharyngeal Carcinoma

Intervention

Epstein-Barr Virus Specific Immunotherapy

Study Arms / Comparison Groups

 Biological/Vaccine
Description:  'Epstein-Barr Virus Specific Immunotherapy' given intravenously on Days 1 and 14

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

20

Start Date

January 23, 2009

Completion Date

December 2021

Primary Completion Date

June 2021

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jochen Lorch, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00834093

Organization ID

08-292

Secondary IDs

R21CA132279-01A1

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Brigham and Women's Hospital

Study Sponsor

Jochen Lorch, MD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

November 2020