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Tracking Information | |
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First Received Date ICMJE | August 10, 2011 |
Last Updated Date | February 10, 2012 |
Start Date ICMJE | November 2010 |
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Local tumor response to I-PDT with Temoporfin [ Time Frame: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment ] [ Designated as safety issue: No ] Longitudinal changes in tumor size and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT). |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT01415986 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] The change in the overall score of the University of Washington quality of life questionnaire (UW-QOLQ). |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers |
Official Title ICMJE | Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY |
Brief 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. |
Detailed Description | 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 ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE | Squamous Cell Carcinoma of the Head and Neck |
Intervention ICMJE |
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Study Arms | |
Publications * | Lou PJ, Jäger HR, Jones L, Theodossy T, Bown SG, Hopper C. Interstitial photodynamic therapy as salvage treatment for recurrent head and neck cancer. Br J Cancer. 2004 Aug 2;91(3):441-6. |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Active, not recruiting |
Estimated Enrollment ICMJE | 5 |
Completion Date | |
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 95 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT01415986 |
Other Study ID Numbers ICMJE | UAMS IRB 114294 |
Has Data Monitoring Committee | No |
Responsible Party | University of Arkansas |
Study Sponsor ICMJE | University of Arkansas |
Collaborators ICMJE |
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Investigators ICMJE | |
Information Provided By | University of Arkansas |
Verification Date | February 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |