T-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00609219

Purpose

RATIONALE: T lymphocytes treated in the laboratory may help the body build an effective immune response to kill tumor cells in patients with Epstein-Barr virus infection.

PURPOSE: This phase I trial is studying the side effects and best way to give T-lymphocytes in treating patients with Epstein-Barr virus-positive nasopharyngeal cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes Genetic: polymerase chain reaction Other: immunoenzyme technique Other: laboratory biomarker analysis	Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	ADMINISTRATION OF EBV-SPECIFIC T-LYMPHOCYTES TO PATIENTS WITH EBV-POSITIVE NASOPHARYNGEAL CARCINOMA

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety of two IV injections of autologously derived Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTLs) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Feasibility of generating EBV-specific cytotoxic T-cell lines [ Designated as safety issue: No ]
Survival, immunological efficacy, and antitumor effects of EBV-specific CTL lines [ Designated as safety issue: No ]
Safety of an extended dosage regimen [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2001
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the safety of two intravenous injections of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in patients with active nasopharyngeal carcinoma.

Secondary

To determine the feasibility of generating EBV-specific CTL lines from these patients.
To determine the survival, immunological efficacy, and antitumor effects of EBV-specific CTL lines from these patients.
To obtain information, preliminarily, on the safety of an extended dosage regimen and response in these patients.

OUTLINE: This is a multicenter study.

Patients receive autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) IV over 1-10 minutes on days 0 and 14. Patients achieving partial response or stable disease at 8 weeks or during subsequent evaluations may receive up to 6 additional infusions of CTLs at 1-3 months interval.

Patients undergo blood sample collection at baseline and periodically during study for immune function studies. Samples are analyzed by tetramer analysis, enzyme-linked immunospot or CTL precursor assays, cytotoxicity assays for evaluation of specificity of response, and by polymerase chain reaction for EBV DNA persistence. Tissue cells from paraffin blocks are analyzed for expression of EBERS and LMP-1.

After completion of study therapy, patients are followed every 3 months for up to 12 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of Epstein-Barr virus-positive nasopharyngeal carcinoma meeting 1 of the following criteria:
- In first or subsequent relapse
- Primary refractory disease
- High-risk disease (i.e., T3 or T4, or node-positive)

PATIENT CHARACTERISTICS:

Karnofsky performance status 50-100%
Life expectancy > 6 weeks
Bilirubin < 2 times normal*
SGOT < 3 times normal*
Hemoglobin > 8.0 g/dL*
Creatinine < 2 times normal for age*
No severe intercurrent infection
Not pregnant
Fertile patients must use effective contraception NOTE: *Patients who would be excluded from the study strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.

PRIOR CONCURRENT THERAPY:

At least one month since other prior investigational therapy
No other investigational therapy concurrently and for ≥ 1 month after cytotoxic T-lymphocyte administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609219

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Helen E. Heslop, MD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000582816, BCM-H-9935, BCM-NPC
Study First Received:	February 2, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00609219 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

recurrent nasopharyngeal cancer
stage II nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer

Study placed in the following topic categories:

Virus Diseases
Nasopharyngeal Carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms

Stomatognathic Diseases
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Recurrence
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

Nasopharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Diseases
Nasopharyngeal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009