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| ID | Type | Description | Link |
|---|---|---|---|
| SINGAPORE-NCC-07-11-NPC |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad5F35-LMP1/LMP2-transduced autologous dendritic cells | Biological | |||
| celecoxib | Drug | |||
| flow cytometry | Other | |||
| immunoenzyme technique | Other | |||
| laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate (CBR) (complete response [CR], partial response [PR], and stable disease [SD] for ≥ 14 weeks) as defined by RECIST criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (CR and PR) | ||
| Overall survival | ||
| Progression-free survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed nasopharyngeal carcinoma (NPC)
Measurable disease
Meets 1 of the following criteria:
No active CNS metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 3 months
Hemoglobin ≥ 8.5 g/dL
Serum bilirubin ≤ 1.5 times upper limit of normal
ALT or AST ≤ 5 times normal
Creatinine clearance ≥ 40 mL/min
Left ventricular ejection fraction ≥ 45% by MUGA
Corrected DLCO > 50% of predicted
No active or prior gastrointestinal bleeding
No history of adverse reaction to NSAIDs or sensitivity to celecoxib
No cardiac disease, including any of the following:
No pulmonary disease, including any of the following:
No cerebrovascular accident
No transient ischemic attack
No HIV positivity
No active uncontrolled infection
No symptomatic leukoencephalopathy or other neuropsychiatric abnormalities
Not pregnant or nursing
Negative pregnancy test
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Toh Han Chong, MD, MBBS, MRCP | National Cancer Centre, Singapore | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre - Singapore | Singapore | 169610 | Singapore |
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| Toxicity profile |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D005434 | Flow Cytometry |
| D007124 | Immunoenzyme Techniques |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
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