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

• 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 ]
  

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.

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