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Photodynamic Therapy for Early Head and Neck Tumors

Head and Neck Tumors Clinical Trial

Official title:
Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Clinical Trial Summary

This is a study to evaluate the safety and find the highest tolerable dose of Levulan® and Photodynamic Therapy (PDT) for premalignant tumors of the head and neck. Subjects will receive Levulan® by mouth and will undergo PDT. Levulan® goes throughout the body, but gets retained in cancer cells more than non-cancer cells. After 4-6 hours, the targeted area is treated with laser light which activates the Levulan® to kill the cells that contain it.

Clinical Trial Description

Overall Objectives:

The primary objectives of the study are to evaluate the toxicities associated with Levulan®-mediated photodynamic therapy in pre-malignant head and neck lesions, and to evaluate the toxicities of continuous vs. fractionated light treatment. The secondary objectives are to assess the efficacy of Levulan®-mediated photodynamic therapy in pre-malignant head and neck lesions, and to assess the efficacy of fractionated versus continuous light treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01019954
Study type Interventional
Source Abramson Cancer Center of the University of Pennsylvania
Contact
Status Completed
Phase Phase 1
Start date January 2009
Completion date November 2014
View Details
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