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A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma

Phase 1
18 Years
75 Years
Not Enrolling
Metastatic Nasopharyngeal

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Trial Information

A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma

We are investigating the use of immune cell therapy in metastatic Nasopharyngeal Cancer
(NPC). Recent small studies have shown that EBV specific cytotoxic T cells can be infused
into NPC patients with some good clinical effect including tumor responses. We are trying to
achieve a similar result using a less complex and less costly approach, with Natural Killer
(NK) cells. NK cells are known to recognize tumor and virally infected cells through a
variety of mechanisms. Also, NK cells influence the development of antigen-specific T cell
responses via reciprocal interactions with dendritic cells and the secretion of IFNγ.

This is a pilot clinical trial to study the feasibility of collecting, manipulating , and
infusing autologous enriched NK cells activated by short-term incubation in IL-2.
Leukapheresis units will be collected from eligible patients with NPC. NK cells will be
selected and activated with IL-2 prior to re-infusion. Patients will receive low dose IL-2
after infusion of activated NK cells. Post infusion monitoring will include peripheral blood
T cell subsets, cytokine secretion and serum cytokine levels. The parameters will be
correlated to clinical observations. If clinical efficacy is shown, our protocol could
represent a simple way of harnessing the immune system of the patient for treatment of this
disease. This study will also serve as platform technology development for later trials
involving manipulating cell therapy products.

Inclusion Criteria:

- Biopsy proven, metastatic nasopharyngeal carcinoma (NPC) (WHO grade III) and
measurable metastatic disease.

- ECOG performance status <2.

- Life expectancy greater than 6 months.

- Patient must have adequate access for leukapheresis (vein or central line)

- Patients must have normal organ and marrow function as defined below:

1. leukocytes >3,500/μl, absolute neutrophil count >1,500/μl, platelets

2. Organ function tests:

3. total bilirubin <1.5X normal, AST(SGOT) / ALT(SGPT) <2.5 X of normal or <5X in
the case of patients with liver metastases;

4. creatinine <1.5X normal institutional limits or a calculated creatinine
clearance of > 50 mls/min.

- Negative pregnancy test within 4 weeks of enrollment in women of child-bearing age.

- Patients with fertility/child bearing potential must agree to avoid pregnancy.

- Age 18 and older

- Patients must have received at least one prior systemic treatments for "metastatic
nasopharyngeal carcinoma".Neoadjuvant chemotherapy or concurrent chemoradiation
administered for localized disease does is not considered a line of prior treatment.

- Patient's last dose of systemic chemotherapy must have been given at least 4 weeks
prior to the beginning of study treatment. Local radiation therapy will be allowed
only if there are other sites of measurable disease.

- Patients must have at least one site of measurable disease. Sites of measurable
disease which has been irradiated can be used if greater than 60 days has passed
between the completion of radiation treatment and the start of NK cell treatment.

Exclusion Criteria:

- Patients with active infections requiring oral or intravenous antibiotics are not
eligible for entry onto the study until resolution of the infection.

- History of HIV infection, chronic active Hepatitis B or C.

- Patients with prior or currently active autoimmune disease requiring management with
systemic immunosuppression are not eligible. Asthma or chronic obstructive pulmonary
disease that does not require daily systemic corticosteroids is acceptable.

- Enrollment on another experimental treatment within 28 days of starting treatment on
this study.

- Systemic steroids within 28 days of starting study treatment.

- Uncontrolled medical problems.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alvin Seng Cheong Wong, MBBS, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Metastatic Nasopharyngeal
  • Carcinoma
  • Nasopharyngeal Neoplasms