A Phase 2 interventional study of Ad5F35-LMP1/LMP2-transduced autologous dendritic cells and celecoxib in Head and Neck Cancer, sponsored by National Cancer Centre, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by National Cancer Centre, Singapore · Phase 2, Interventional, and Treatment
RATIONALE: Vaccines made from a gene-modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with celecoxib works in treating patients with metastatic nasopharyngeal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo blood collection for the preparation of the autologous dendritic cell (DC) vaccine. Immature DCs are transduced with latent membrane protein-1 (LMP-1) and latent membrane protein-2 (LMP-2) using the adenoviral vector 5F35. Beginning 1 week after blood collection, patients receive vaccination with autologous DCs transduced with AD5F35-LMP-1/LMP-2 intradermally every 2 weeks for a total of 5 vaccinations. Patients also receive celecoxib twice a day beginning 1 week before the first vaccination and continuing for up to 6 weeks after completion of the last vaccination.
Patients who demonstrate clinical benefit after completion of 5 courses of vaccination may continue to receive the DC vaccine alone off study every 2 weeks until disease progression (based on CT scan findings) or at the investigator's discretion.
Patients undergo blood and tumor tissue sample collection periodically for laboratory studies. Blood samples are analyzed using MHC tetramer analysis; enzyme-linked immunospot (ELISPOT) analysis; EBV DNA titers to assess response; and flow cytometry to assess lymphocyte kinetics. Tumor tissue samples are used for immunological studies. Delayed-type hypersensitivity is also assessed.
After completion of study treatment, patients are followed monthly for up to 1 year.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 35 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →National Cancer Centre, Singapore is the lead sponsor of 116 studies on the registry; 30 are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically confirmed nasopharyngeal carcinoma (NPC)
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
No pulmonary disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Clinical benefit rate (CBR) (complete response [CR], partial response [PR], and stable disease [SD] for ≥ 14 weeks) as defined by RECIST criteria
Response rate (CR and PR)
Overall survival
Progression-free survival
Toxicity profile
This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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National Cancer Centre, Singapore