Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	Other	NPC-CTL OCRN #03-NOV-0422, NCT00706316

Trial Description

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 organs, treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the development of NPC, and studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytototoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Toronto Western Hospital

Lillian L. Siu

Principal Investigator

Lillian Siu		Ph: 416 946 2911
		Email: lillian.siu@uhn.on.ca

Canada
Ontario
	Toronto
	Princess Margaret Hospital
		Lillian Siu	Ph: 416 946 2911
			Email: lillian.siu@uhn.on.ca
		Lillian L. Siu	Principal Investigator
		Armand Keating	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00706316
Information obtained from ClinicalTrials.gov on March 18, 2009