AzTrials
AzTrials

Nasopharyngeal CancerPhase 1NCT03282617

Dendritic Cell Therapy With CD137L-DC-EBV-VAX in Locally Advanced Stage IV or Locally Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase 1 study testing CD137L-DC-EBV-VAX in people with Nasopharyngeal Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is carried out to find out the safety and recommended dose of CD137L-DC-EBV-VAX in nasopharyngeal cancer. CD137L-DC-EBV-VAX is a product made from one of our own immune system cells (dendritic cell, DC). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Nasopharyngeal Cancer
What is being tested?
CD137L-DC-EBV-VAX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteSingapore
Study dates
14 Aug 2017to 14 Aug 2020
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Any of the following:
  • Chemotherapy ≤ 4 weeks prior to CD137L-DC-EBV-VAX study treatment.
  • Radiotherapy ≤ 4 weeks prior to CD137L-DC-EBV-VAX study treatment.
  • Nitrosoureas or Mitomycin C ≤ 4 weeks prior to registration
  • NOTE: Prior palliative radiotherapy to bone metastases is allowed ≤ 4 weeks prior to registration. Prior immunotherapy with immune checkpoint inhibitors will not be allowed.
  • Prior investigational agents ≤ 4 weeks prior to registration.
Show all 16Show fewer
  • Known allergy to Tetanus and/or Diphtheria toxoid.
  • Known brain metastases or leptomeningeal metastases. NOTE: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. >10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration. Patients with treated brain metastases who are deemed clinically stable and without radiological progression on PET, MRI or CT scan performed ≤ 8 weeks of study entry, are not excluded. NOTE: Primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa(e) are not regarded as brain metastases and are not excluded.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. NOTE: These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if <10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.

Trial locations and contacts

1 site in 1 country.

Boon Cher Goh contact

(65) 6779 5555

phcgbc@nus.edu.sg

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore

    Boon Cher Goh, MBBS, MRCP, 65-6772-4617, Boon_Cher_Goh@nuhs.com.sg

    Boon Cher Goh, MBBS, MRCP

    Recruiting

Other trials in Singapore

About this study

This study is carried out to find out the safety and recommended dose of CD137L-DC-EBV-VAX in nasopharyngeal cancer. CD137L-DC-EBV-VAX is a product made from one of our own immune system cells (dendritic cell, DC). Dendritic cells are immune cells that help to stimulate our body's T lymphocytes to fight cancer by presenting specific proteins from the cancer cells. The investigators have developed in the laboratory a highly effective dendritic cell which is primed to activate T cells with the Epstein-Barr virus (EBV) proteins. It is hoped that this will stir an immune response to recognize NPC cells and kill them as part of body's immune surveillance system.

Read the detailed description

This study will involve two cohorts of patients, A and B. Patients are invited because they have either (A) locally recurrent or metastatic nasopharyngeal cancer; or (B) stage 4 locally advanced nasopharyngeal cancer (N2 or N3 disease and/or T4) and is known to be associated with a high risk of distant relapse.

This study is carried out to find out the safety and recommended dose of CD137L-DC-EBV-VAX in nasopharyngeal cancer. CD137L-DC-EBV-VAX is a product made from one of our own immune system cells (dendritic cell, DC). Dendritic cells are immune cells that help to stimulate our body's T lymphocytes to fight cancer by presenting specific proteins from the cancer cells. The investigators have developed in the laboratory a highly effective dendritic cell which is primed to activate T cells with the Epstein-Barr virus (EBV) proteins. It is hoped that this will stir an immune response to recognize NPC cells and kill them as part of body's immune surveillance system.

Being tested
CD137L-DC-EBV-VAX
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD137L-DC-EBV-VAXBiological

    Also called Dendritic cell therapy

    Patients will receive CD137L-DC-EBV-VAX at a dose of approximately 5-50 millioncells every 2 weeks, for a total of 5-7 times.

Study groups in NCT03282617
Study groupRoleWhat they receive
locally recurrent or metastatic nasopharyngeal cancerExperimentalThis cohort consists of patients with metastatic or locally recurrent NPC who have received systemic concurrent chemotherapy and have a favourable response of stable disease, partial or complete response. As up to 30% of these patients will suffer from relapse within 5 months of completion of chemotherapy, following definitive treatment, y, and treatment with CD137L-DC-EBV-VAX may activate T cell response against the tumor and prolong time to progression.
Receives: Biological: CD137L-DC-EBV-VAX
stage 4 locally advanced nasopharyngeal cancerExperimentalThis cohort consists of patients with stage 4 locally advanced patients (N2 and N3 disease, and/or T4 disease) who are treated definitely with chemoradiation with curative intent, but who have a high risk of distant relapse. Treatment with CD137L-DC-EBV-VAX may activate antitumor T cell responses and prolong time to relapse.
Receives: Biological: CD137L-DC-EBV-VAX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability and recommended dose of CD137L-DC-EBV-VAX

    Measured: From the start of assessment until study completion, an average of 3 year

Secondary outcomes (3)

  1. Activation of EBV-specific T cell responses

    Measured: From the start of assessment until study completion, an average of 3 year

  2. Antitumor Effect based on Immune Response Criteria (IRC)

    Measured: From the start of assessment until study completion, an average of 3 year

  3. Progression-free survival and overall survival

    Measured: From the start of assessment until study completion, an average of 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2017
  2. Study start14 Aug 2017
  3. Primary completion14 Aug 2019 (estimated)
  4. Study completion14 Aug 2020 (estimated)

Resources

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
Intervention model
Parallel groups
Model description
Patients will be given CD137L-DC-EBV-VAX for about 5 - 7 times and be followed up until a maximum of 3 years from study entry.
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282617
Sponsor's protocol ID
NP01/03/16
Status last verified
Sep 2017
First submitted
12 Sep 2017
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Petersson F. Nasopharyngeal carcinoma: a review. Semin Diagn Pathol. 2015 Jan;32(1):54-73. doi: 10.1053/j.semdp.2015.02.021. Epub 2015 Feb 25.

    PubMed 25769204

  • Lee AW, Ma BB, Ng WT, Chan AT. Management of Nasopharyngeal Carcinoma: Current Practice and Future Perspective. J Clin Oncol. 2015 Oct 10;33(29):3356-64. doi: 10.1200/JCO.2015.60.9347. Epub 2015 Sep 8.

    PubMed 26351355

  • Yu MC, Yuan JM. Epidemiology of nasopharyngeal carcinoma. Semin Cancer Biol. 2002 Dec;12(6):421-9. doi: 10.1016/s1044579x02000858.

    PubMed 12450728

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD137L-DC-EBV-VAX in people with Nasopharyngeal Cancer, 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 0 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Boon Cher Goh ((65) 6779 5555, phcgbc@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability and recommended dose of CD137L-DC-EBV-VAX (time frame: From the start of assessment until study completion, an average of 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282617, which also lists 3 linked publications.

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 14 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in