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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00834093

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

163.3

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

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

Actual Study Start Date :

Jan 23, 2009

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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 Names: Cell based vaccine

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 Names:

Cell based vaccine

Outcome Measures

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 [3 years]

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 [3 years]
To evaluate the safety of EBV-specific immunotherapy [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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