search
Back to results

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

Primary Purpose

Metastatic Nasopharyngeal

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Interleukin, NK cells
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Nasopharyngeal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 >100,000/μl.
    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.

Sites / Locations

  • National University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 15, 2008
Last Updated
April 7, 2010
Sponsor
National University Hospital, Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT00717184
Brief Title
A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma
Official Title
A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore

4. Oversight

5. Study Description

Brief Summary
To demonstrate the feasibility of leukapheresis and ex vivo activation of autologous NK cells in patients with metastatic NPC To demonstrate the safety of low dose systemic IL-2 in combination with escalating doses of autologous Ex Vivo Activated NK cells in patients with metastatic NPC To assess immune measurements such as quantitation of regulatory T cells, EBV specific T cells, serum cytokine levels, and NK cell function after treatment with IL-2 and autologous Ex Vivo Activated NK cells
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Nasopharyngeal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interleukin, NK cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: leukocytes >3,500/μl, absolute neutrophil count >1,500/μl, platelets >100,000/μl. Organ function tests: total bilirubin <1.5X normal, AST(SGOT) / ALT(SGPT) <2.5 X of normal or <5X in the case of patients with liver metastases; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvin Seng Cheong Wong, MBBS, MRCP
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
16364519
Citation
Farag SS, Caligiuri MA. Human natural killer cell development and biology. Blood Rev. 2006 May;20(3):123-37. doi: 10.1016/j.blre.2005.10.001. Epub 2005 Dec 20.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs