Metastatic NasopharyngealPhase 1NCT00717184
A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma
A Phase 1 study testing Interleukin, NK cells in people with Metastatic Nasopharyngeal, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Nasopharyngeal
- What is being tested?
- Interleukin, NK cells
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- May 2007to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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
Read the 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.
- Conditions
- Metastatic Nasopharyngeal
- Being tested
- Interleukin, NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin, NK cellsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic NasopharyngealStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Alvin Seng Cheong Wong, MBBS, MRCP, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717184
- Sponsor's protocol ID
- NP01/02/06
- Status last verified
- Apr 2010
- First submitted
- 15 Jul 2008
- Last updated
- 9 Apr 2010
- Results posted
- No
Publications
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.
PubMed 16364519
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00717184
- Acronym / sponsor ID
- NP01/02/06
- Conditions
- Metastatic Nasopharyngeal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2007
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin, NK cells | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
- Background: PubMed 16364519Farag 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvin Seng Cheong Wong, MBBS, MRCP principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interleukin, NK cells in people with Metastatic Nasopharyngeal, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00717184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2010.