Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers
Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Arkansas
Collaborators:
Biolitec Pharma Ltd. Erasmus Medical Center The Netherlands Cancer Institute