Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers
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.
Squamous Cell Carcinoma of the Head and Neck
Device: Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY|
- Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin [ Time Frame: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment ] [ Designated as safety issue: No ]Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).
- Changes in the Quality of Life (QoL) [ Time Frame: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment. ] [ Designated as safety issue: No ]The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.
|Study Start Date:||November 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Experimental: Subjects receiving 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.
Other Name: FoscanDevice: 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.
Other Name: Ceralas PDT 652, CeramOptec GmbH
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415986
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|