Status:
COMPLETED
Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 c...
Detailed Description
* The first step in this research study is the peripheral blood collection. Approximately 60-90cc's will be collected intravenously and used to prepare the EBV immunotherapy product. It takes about 12...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2016
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00431210
Start Date
February 1 2007
End Date
January 26 2016
Last Update
April 18 2017
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115