Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors
|ClinicalTrials.gov Identifier: NCT01043016|
Recruitment Status : Unknown
Verified January 2010 by Fujian Longhua Pharmaceutical Co. Ltd.
Recruitment status was: Recruiting
First Posted : January 6, 2010
Last Update Posted : January 6, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer Esophageal Cancer||Procedure: Photodynamic therapy||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||April 2010|
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
- Maximum 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043016
|Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Hui Lin 0591-28059198 firstname.lastname@example.org|
|Principal Investigator: guo l xu|
|Principal Investigator:||guo l xu||Sun Yat-sen University|