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

NCT03282617 | Unknown Phase 1

• 1 other identifier: NP01/03/16
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability and recommended dose of CD137L-DC-EBV-VAX

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

Secondary Outcomes (3)

• Activation of EBV-specific T cell responses

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

• Antitumor Effect based on Immune Response Criteria (IRC)

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

• Progression-free survival and overall survival

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

Study Arms (2)

locally recurrent or metastatic nasopharyngeal cancer

EXPERIMENTAL

This 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.

Biological: CD137L-DC-EBV-VAX

stage 4 locally advanced nasopharyngeal cancer

EXPERIMENTAL

This 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.

Biological: CD137L-DC-EBV-VAX

Interventions

CD137L-DC-EBV-VAX BIOLOGICAL

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.

Also known as: Dendritic cell therapy

locally recurrent or metastatic nasopharyngeal cancer; stage 4 locally advanced nasopharyngeal cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- 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.
• 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).

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (3)

• 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.

  PMID: 25769204 BACKGROUND

• 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.

  PMID: 26351355 BACKGROUND

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

  PMID: 12450728 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Boon Cher Goh

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boon Cher Goh

CONTACT

(65) 6779 5555; phcgbc@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: August 14, 2017
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2020
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)