NCT01043016

Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Fujian Longhua Pharmaceutical Co. Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Skin Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	Photodynamic therapy	patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2010-01-06
• Last updated: 2010-01-06

Locations

1 site across 1 country: China