Clinical trial · Interventional
Vaccine Therapy and Celecoxib in Treating Patients With Metastatic Nasopharyngeal Cancer
Phase II Clinical Trial of Tumour Vaccination By Intradermal Delivery of Autologous Dendritic Cells Transduced With Adenoviral Vector (AD5F35) Expressing Latent Membrane Protein-1 (LMP-1) and Latent Membrane Protein-2 (LMP-2) Genes in Combination With Celecoxib in Patient With Metastatic Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5F35-LMP1/LMP2-transduced autologous dendritic cells | Biological | — | UNRESOLVED |
| celecoxib | Drug | Celecoxib | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical benefit rate (CBR) (complete response [CR], partial response [PR], and stable disease [SD] for ≥ 14 weeks) as defined by RECIST criteria
Secondary outcomes (4)
- measure
- Response rate (CR and PR)
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Toxicity profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed nasopharyngeal carcinoma (NPC) * Metastatic disease * WHO type II/III disease * Measurable disease * Meets 1 of the following criteria: * Progression on one or more lines of polychemotherapy for treatment of metastatic disease * Failed non-myeloablative hematopoietic stem cell transplant * 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: * Symptomatic congestive heart failure * Active angina pectoris * High-risk uncontrolled arrhythmia * Uncontrolled hypertension * No pulmonary disease, including any of the following: * Severe chronic obstructive lung disease * Uncontrolled large pleural effusion * Severe restrictive lung disease * 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: * See Disease Characteristics * Prior celecoxib allowed * At least 28 days since prior chemotherapy * At least 100 days since prior non-myeloablative hematopoietic stem cell transplant * At least 2 months since prior donor lymphocyte infusions * More than 28 days since prior participation in another clinical trial with any investigational drugs * No other concurrent experimental drugs * No other concurrent anticancer therapy * No concurrent anticoagulation with warfarin or low molecular weight heparin * No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin
References
Publications (0)
Data not yet available