A Phase I Trial Evaluating the Administration of Epstein Barr Virus (EBV)-Specific Cytotoxic T-Lymphocytes (CTLs) to Patients With Recurrent or Metastatic EBV-Positive Nasopharygneal Cancer (NPC)
- Any patient with EBV positive NPC, with recurrent and/or metastatic disease
- Patients with a life expectancy > 3 months.
- Patients with an ECOG performance status of 0, 1 or 2
- No severe intercurrent infection.
- Patients who are able to give informed consent.
- Patients with:
- bilirubin <2x normal,
- SGOT (AST) and SGPT (ALT) <3x normal,
- Hgb >80 g/L,
- absolute neutrophil count (ANC) > 1.5 x 109/L,
- and platelets > 100 x 109/L.
- Patients with a creatinine <2x normal for age
- Patients should have been off any chemotherapy or other investigational therapy for
at least 4 weeks prior to entry in this study.
- Patients should have completed any prior radiation therapy for at least 3 weeks prior
to entry in this study. Exception may be made, however, for low-dose,
non-myelosuppressive radiotherapy, but this must be discussed with Principal
- All patients must have measurable disease, with minimum indicator lesions size as
- CT scan > 2 cm (or > 1 cm if spiral CT scan is used)
- Ultrasound > 2 cm
- Chest x-ray > 2 cm
- Physical exam > 1 cm (skin lesions, nodes, soft tissue masses)
- Patients with a life expectancy of < 3 months.
- Patients with an ECOG performance status of >2.
- Patients with a severe intercurrent infection.
- Patients unable or unwilling to give informed consent.
- Patients with a bilirubin >2x normal.
- SGOT (AST) and SGPT (ALT) >3x normal.
- Patients with a creatinine >2x normal for age
- Patients with Hgb < 80 g/L, absolute neutrophil count (ANC) < 1.5 x 109/L, and
platelets < 100 x 109/L.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from
this research. Lactating women are excluded from this study. Patients and their
partners must use an effective birth control method during the study and for 6 months
after. Effective birth control methods are: total abstinence, oral contraceptives,
intrauterine devices, contraceptive implants under the skin or contraceptive
injections. If one of these methods cannot be used, contraceptive foam with a condom
is allowed. The male partner should use a condom.