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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Nasopharyngeal Cancer

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To determine the safety of autologous EBV-specific CTLs in patients with nasopharyngeal cancer

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network - Princess Margaret Hospital

Authority:

Canada: Health Canada

Study ID:

NPC-CTL

NCT ID:

NCT00706316

Start Date:

December 2007

Completion Date:

July 2010

Related Keywords:

  • Nasopharyngeal Cancer
  • Nasopharygneal Cancer
  • Epstein Barr Virus
  • (EBV)-Specific Cytotoxic T-Lymphocytes
  • Recurrent
  • Metastatic
  • EBV-Positive Nasopharygneal Cancer
  • Nasopharyngeal Neoplasms

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