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NCT01415986 · ClinicalTrials.gov registry record · Phase 2
Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers
A Phase 2 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01415986 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 1 participants.
The verdict
NCT01415986, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study 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.
Interventions
- DRUG Temoporfin
- DEVICE Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01415986
The ClinicalTrials.gov registry entry for NCT01415986 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temoporfin is the first listed.
NCT01415986 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01415986 about?
NCT01415986 is a clinical study titled "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...
What is the current status of trial NCT01415986?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2010-11. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01415986?
The interventions under investigation include: Temoporfin (DRUG), Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH) (DEVICE).
Who is sponsoring clinical trial NCT01415986?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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