Photodynamic Therapy in Treating Patients With Skin Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00002975
First received: November 1, 1999
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: June 28, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-melanomatous Skin Cancer
Precancerous Condition
Intervention: Drug: aminolevulinic acid

  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
Study was activated in February, 1997, which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI died and left incomplete data, and study was terminated in April, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Photodynamic Therapy Using 20% Topical ALA 4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation

Participant Flow:   Overall Study
    Photodynamic Therapy Using 20% Topical ALA  
STARTED     180  
Treated With Study Therapy     175  
COMPLETED     175  
NOT COMPLETED     5  



  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.
Treated Patients

Reporting Groups
  Description
Photodynamic Therapy Using 20% Topical ALA 4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation

Baseline Measures
    Photodynamic Therapy Using 20% Topical ALA  
Number of Participants  
[units: participants]
  175  
Age  
[units: years]
Mean ± Standard Deviation
  58.0  ± 16.0  
Gender  
[units: participants]
 
Female     88  
Male     87  



  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: One Year ]


  Serious Adverse Events


  Other Adverse Events


  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
Study was activated prior to RPCI putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI died and left incomplete data. Efficay and safety data were not analyzed.


  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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300


No publications provided


Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00002975     History of Changes
Other Study ID Numbers: CDR0000065494, RPCI-DS-96-55, NCI-G97-1224
Study First Received: November 1, 1999
Results First Received: June 28, 2013
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration