Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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