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Treatment of Oral Premalignant Lesions With 5-ALA PDT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00571974
First received: December 5, 2007
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
Results First Received: May 11, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukoplakia
Erythroplakia
Interventions: Device: PDL-585, ScleroPLUS laser
Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)
Procedure: Fluorescence Diagnosis Imaging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were identified in the head and neck oncology clinic and enrolled into the study within the time period of January 1, 2007 to November 18, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screen failure did meet incl./excl. criteria

Reporting Groups
  Description
Phase I

To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.

The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD).
Phase II During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.

Participant Flow for 2 periods

 Period 1:   Phase I
    Phase I     Phase II  
STARTED     9     0  
COMPLETED     9     0  
NOT COMPLETED     0     0  

Period 2:   Phase II
    Phase I     Phase II  
STARTED     0     21 [1]
COMPLETED     0     17  
NOT COMPLETED     0     4  
[1] 3 participants are from phase I



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I

To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.

The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD).
Phase II During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
Total Total of all reporting groups

Baseline Measures
    Phase I     Phase II     Total  
Number of Participants  
[units: participants]
 		  11     18     29  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 80 years     11     18     29  
>=80 years     0     0     0  
Gender  
[units: participants]
 		     
Female     7     7     14  
Male     4     11     15  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose   [ Time Frame: Day 2 ]
  Show Outcome Measure 1

2.  Primary:   The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).   [ Time Frame: Day 90 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Since all but one subject responded to treatment, no correlative analysis of response with change in expression of p53 or Ki-67 was undertaken.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gal Shafirstein, D.Sc.
Organization: Roswell Park Cancer Institute
phone: 716-845-4025
e-mail: Gal.Shafirstein@RoswellPark.org


Publications of Results:


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00571974     History of Changes
Other Study ID Numbers: 51439
Study First Received: December 5, 2007
Results First Received: May 11, 2012
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration