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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099021
First Posted: December 9, 2004
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: October 13, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      19  90.5% 
>=65 years      2   9.5% 
Age 
[Units: Years]
Median (Full Range)
 56.1 
 (27 to 75) 
Gender 
[Units: Participants]
Count of Participants
 
Female      12  57.1% 
Male      9  42.9% 
Region of Enrollment 
[Units: Participants]
 
United States   21 


  Outcome Measures
  Show All Outcome Measures

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 reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Ki 67 Labeling Index   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Apotosis (Cell Death)   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Pigliotazone Gamma Immune Histochemistry   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Cyclooxygenase-2 Staining   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Cyclin D1 and p21 Immune Histochemistry   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Involucrin and Transglutaminase Staining   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining   [ Time Frame: Pre (Day 0) and Post (Week 12) Treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  


  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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00099021     History of Changes
Other Study ID Numbers: NCI-2009-00862
NCI-2009-00862 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000393562
2001LS068
0109 M 07254 ( Other Identifier: University of Minnesota Medical Center-Fairview )
N01-CN-15000 ( Other Identifier: DCP )
N01CN15000 ( Other Identifier: US NIH Grant/Contract Award Number )
First Submitted: December 8, 2004
First Posted: December 9, 2004
Results First Submitted: October 13, 2009
Results First Posted: November 25, 2009
Last Update Posted: December 30, 2016