Vaccine Therapy and Celecoxib in Treating Patients With Metastatic Nasopharyngeal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Celecoxib

Criteria

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