Clinical Research Directory

Inclusion Criteria: 1. . Histologically confirmed squamous cell carcinoma of head and neck. 2. . Locoregional recurrence. 3. . After standard treatment of R/M HNSCC. 4. . Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI). 5. . Lesion selection criteria - at least 1 lesion to be injected must be measurable and greater than or equal to 1.5 cm and longest diameter not exceed 10 cm in principle. 6. . ECOG performance status ≤2. 7. . Age ≧20 years old; and life expectancy of at least 12 weeks. 8. . Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration. 9. . Must not have received anticancer therapy used with an antineoplastic intent, including chemotherapy, immunotherapy, biologic, or any investigational therapy within 14 days prior to the first dose of study drug. 10. . No history of allergic reactions attributed to methylene blue. 11. . Patient consent must be obtained. 12. . Negative pregnancy test, Fertile patients must use effective contraception. Exclusion Criteria: 1. . Presence of central nervous system (CNS) metastases. 2. . The organ function measured within 14 days prior to study entry as defined below: Absolute neutrophil count (ANC) less than 1,000/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤40 ml/min. 3. . Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia. 4. . Documented hypersensitivity to methylene blue compound or compounds of similar chemical or biologic composition. 5. . Pregnant or lactating women.