NCT01415986

Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers

Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Presently, there is no effective treatment for patients with advanced head and neck cancer (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery) in the US. These patients are deemed incurable AHNC. In the European Union (EU), interstitial photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of patients with incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin can provide worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of patients with incurable AHNC. This is a significantly higher rate in comparison to the reported response rate of palliative chemotherapy (6-30%). However, the EU studies did not correlate quantitative tumor response with clinical outcome. In addition, quality of life (QoL) improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated. The objective of this study is to quantify the tumor response and patient's QoL to I-PDT with Temoporfin. Successfully meeting this objective will give us the tools the investigators need to design larger studies to significantly improve the management and QoL of patients with AHNC.

Detailed description

This is a non-randomize, open label, Pilot phase II study with 5 consenting subjects. The specific aims of this study are: Aim 1: Quantitate local tumor response in patients with incurable AHNC treated with I-PDT with Temoporfin. Aim 2: Evaluate the changes in QoL in patients with incurable AHNC treated with I-PDT with Temoporfin.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Temoporfin	A single dose of 0.15 mg of Temoporfin per kilogram of body weight will be administered by slow intravenous injection into a deep vein (such as the antecubital vein) in not less than 6 minutes.
DEVICE	Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)	Light dose of 20 J/cm, at a rate of 100 mW/cm, will be delivered to the target tumor and margins, within 200 seconds.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-08-01
• Completion: 2012-03-01
• First posted: 2011-08-12
• Last updated: 2012-12-03
• Results posted: 2012-12-03

Locations

1 site across 1 country: United States