Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma

Completed · Phase 1

Conditions studied: Nasopharyngeal Carcinoma

In brief

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.

Key facts

Study ID

NCT00431210

Run by

Dana-Farber Cancer Institute

People needed

28

Starts

2007-02-01

Expected to finish

2016-01-26

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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