Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers
|ClinicalTrials.gov Identifier: NCT01415986|
Recruitment Status : Terminated (The patient was "lost to follow-up" and the PI left the institution.)
First Posted : August 12, 2011
Results First Posted : December 3, 2012
Last Update Posted : December 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Temoporfin Device: Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||March 2012|
|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: Foscan
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.
Other Name: Ceralas PDT 652, CeramOptec GmbH
- 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 ]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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415986
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|