Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00099021
First received: December 8, 2004
Last updated: May 5, 2014
Last verified: March 2013
Results First Received: October 13, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Head and Neck Cancer
Oral Leukoplakia
Intervention: Drug: pioglitazone hydrochloride

  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
No text entered.

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
Pioglitazone Patients Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.

Participant Flow:   Overall Study
    Pioglitazone Patients  
STARTED     21  
COMPLETED     21  
NOT COMPLETED     0  



  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
Pioglitazone Patients Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.

Baseline Measures
    Pioglitazone Patients  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     2  
Age  
[units: years]
Median ( Full Range )
  56.1  
  ( 27 to 75 )  
Gender  
[units: participants]
 
Female     12  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures
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1.  Primary:   Patients' Overall Response   [ Time Frame: Week 16 (4 weeks post dose) ]

2.  Secondary:   Patients' Clinical Response   [ Time Frame: Week 16 (4 weeks post dose) ]

3.  Secondary:   Patients' Histological (Tissue) Response   [ Time Frame: Week 16 (4 weeks post dose) ]

4.  Secondary:   Nf Kappa B p65   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

5.  Secondary:   Ki 67 Labeling Index   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

6.  Secondary:   Apotosis (Cell Death)   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

7.  Secondary:   Pigliotazone Gamma Immune Histochemistry   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

8.  Secondary:   Cyclooxygenase-2 Staining   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

9.  Secondary:   Cyclin D1 and p21 Immune Histochemistry   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

10.  Secondary:   Involucrin and Transglutaminase Staining   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

11.  Secondary:   Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No

12.  Secondary:   Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet posted.   Anticipated Posting Date:   12/2009   Safety Issue:   No


  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 closed prior to full accrual because results were very good and funding was discontinued (R-01 application was filed.)

Immunohistochemistry (Outcomes #4 through #12) were not done due to laboratory limitations of time.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Frank G. Ondrey, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-625-3200
e-mail: ondre002@umn.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00099021     History of Changes
Other Study ID Numbers: NCI-2009-00862, NCI-2009-00862, CDR0000393562, 2001LS068, 0109 M 07254, N01-CN-15000, N01CN15000
Study First Received: December 8, 2004
Results First Received: October 13, 2009
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board