Status:
COMPLETED
Administration of Epstein Barr Virus - Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer
Lead Sponsor:
University Health Network, Toronto
Conditions:
Nasopharyngeal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or spreads to other org...
Detailed Description
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy. However, the treatment of this cancer can lead t...
Eligibility Criteria
Inclusion
- 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 Investigator(s).
- All patients must have measurable disease, with minimum indicator lesions size as follows:
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00706316
Start Date
December 1 2007
End Date
November 1 2012
Last Update
July 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9