Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00734994
First received: May 4, 2008
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: August 1, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Transitional Cell Carcinoma of Bladder
Superficial Bladder Cancer
Interventions: Device: Hyperthermia System
Drug: Mitomycin C

  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
Recruitment Period: 09/2008-09/2010 Location: Urology and Radiation Oncology Clinics

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
Mitomycin C With Hyperthermia and Recurrent Bladder Cancer Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer

Participant Flow:   Overall Study
    Mitomycin C With Hyperthermia and Recurrent Bladder Cancer  
STARTED     15  
COMPLETED     14  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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
Mitomycin C With Hyperthermia Mitomycin C and Hyperthermia

Baseline Measures
    Mitomycin C With Hyperthermia  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     8  
Gender  
[units: participants]
 
Female     2  
Male     13  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     15  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures

1.  Primary:   Safety   [ Time Frame: During Treatment Phase average 6 weeks ]

2.  Secondary:   Time to Second Recurrence   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   11/2011   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


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


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Zeljko Vujaskovic, MD, PhD
Organization: Duke University, Department of Radiation Oncology
phone: 919 668-5221
e-mail: vujas001@mc.duke.edu


No publications provided


Responsible Party: Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00734994     History of Changes
Other Study ID Numbers: Pro00003239
Study First Received: May 4, 2008
Results First Received: August 1, 2011
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration