The purpose of this study is to determine the safety and maximum tolerated dose of Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer and esophageal cancer). Projected accrual: A total of 18-24 patients will be accrued for this study.
Photocyanine injection is a type of cyanine compound, which was invented in Fuzhou university by Professor Chen; it's maximum absorption wave is 670 nm. Patients receive intravenous injection of Photocyanine injection, and 24 hours later, patients undergo photodynamic therapy. Cohorts of 3-6 patients receive escalating doses of Photocyanine Injection and photodynamic therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients experiences dose-limiting toxicity. Three additional patients are treated at the MTD. After completion of study therapy, patients are followed for up to 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later
Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMaximum tolerated dose
Time frame: one month
Treatment efficacy as measured by computed tomography (CT) or magnetic resonance imaging (MRI) and endoscopy exam 3 weeks after the start of study treatment according to the Response Evaluation Criteria In Solid Tumors (RECIST) standard
Time frame: six weeks
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