Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers
Public ClinicalTrials.gov record NCT01415986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01415986
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1 participant
Conditions and interventions
Conditions
Interventions
- Temoporfin Drug
- Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH) Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years to 95 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Jul 31, 2011
- Completion
- Feb 29, 2012
- Last update posted
- Dec 2, 2012
2010 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01415986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 2, 2012 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01415986 live on ClinicalTrials.gov.