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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717184
First Posted: July 17, 2008
Last Update Posted: April 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National University Hospital, Singapore
  Purpose
  1. To demonstrate the feasibility of leukapheresis and ex vivo activation of autologous NK cells in patients with metastatic NPC
  2. 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
  3. 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

Condition Intervention Phase
Metastatic Nasopharyngeal Drug: Interleukin, NK cells Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Study Start Date: May 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717184


Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Alvin Seng Cheong Wong, MBBS, MRCP National University Hospital, Singapore
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00717184     History of Changes
Other Study ID Numbers: NP01/02/06
First Submitted: July 15, 2008
First Posted: July 17, 2008
Last Update Posted: April 9, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases