Vaccine Therapy and Celecoxib in Treating Patients With Metastatic Nasopharyngeal Cancer

NCT00589186 | Unknown Phase 2

• 2 other identifiers: CDR0000579355SINGAPORE-NCC-07-11-NPC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer

Keywords

stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent lymphoepithelioma of the nasopharynx

Outcome Measures

Primary Outcomes (1)

• 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)

• Response rate (CR and PR)

• Overall survival

• Progression-free survival

• Toxicity profile

Interventions

Ad5F35-LMP1/LMP2-transduced autologous dendritic cells BIOLOGICAL

celecoxib DRUG

flow cytometry OTHER

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Celecoxib; Flow Cytometry; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Toh Han Chong, MD, MBBS, MRCP

  National Cancer Centre, Singapore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 9, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Last Updated: December 18, 2013

Record last verified: 2008-12

Locations

SG (1)