Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
Recruitment status was: Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors|
- Maximum tolerated dose [ Time Frame: one month ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||April 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Photocyanine injection
Patients receive intravenous injection of Photocyanine injection from dosage of 0.1 mg/kg,0.2 mg/kg,0.33 mg/kg,0.5 mg/kg to 0.6 6mg/kg till the dose-limiting effect occur.
Procedure: Photodynamic therapy
patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043016
|Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||guo l xu||Sun Yat-sen University|