Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma

NCT00431210 | Completed Phase 1 DMC

• 1 other identifier: 06-179
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

NPC; EPV

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• The ability to collect specimens and measure potential biologic correlate of response to therapy

  2 years

• time to progression in this patient population

  2 years

• median duration of response and median overall survival in this cohort of participants.

  2 years

Study Arms (1)

Biological/Vaccine

EXPERIMENTAL

Epstein-Barr virus-specific adoptive T-cells immunotherapy given intravenously on Days 1 and 14

Biological: Epstein-Barr virus-specific adoptive T-cells immunotherapy

Interventions

Epstein-Barr virus-specific adoptive T-cells immunotherapy BIOLOGICAL

Given intravenously on Day 1 and Day 14

Biological/Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jochen Lorch, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: February 1, 2007
• Primary Completion: June 30, 2015
• Study Completion: January 26, 2016
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)