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

2014-08-27 03:16:53 | BioPortfolio

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.

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Skin Cancer

Intervention

Photodynamic therapy

Location

Department of Endoscopy and Laser,Sun Yat-Sen University,Cancer Center
Guangzhou
Guangdong
China
510060

Status

Recruiting

Source

Fujian Longhua Pharmaceutical Co. Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:53-0400

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Medical and Biotech [MESH] Definitions

The purified component of HEMATOPORPHYRIN DERIVATIVE, it consists of a mixture of oligomeric porphyrins. It is used in photodynamic therapy (HEMATOPORPHYRIN PHOTORADIATION); to treat malignant lesions with visible light and experimentally as an antiviral agent. It is the first drug to be approved in the use of PHOTODYNAMIC THERAPY in the United States.

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A complex mixture of monomeric and aggregated porphyrins used in the photodynamic therapy of tumors (HEMATOPORPHYRIN PHOTORADIATION). A purified component of this mixture is known as DIHEMATOPORPHYRIN ETHER.

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