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

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ClinicalTrials.gov Identifier: NCT00734994
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : August 30, 2011
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Mark Dewhirst, Duke University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Transitional Cell Carcinoma of Bladder
Superficial Bladder Cancer
Interventions Device: Hyperthermia System
Drug: Mitomycin C
Enrollment 15
Recruitment Details Recruitment Period: 09/2008-09/2010 Location: Urology and Radiation Oncology Clinics
Pre-assignment Details  
Arm/Group Title Mitomycin C With Hyperthermia and Recurrent Bladder Cancer
Hide Arm/Group Description Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Mitomycin C With Hyperthermia
Hide Arm/Group Description Mitomycin C and Hyperthermia
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  46.7%
>=65 years
8
  53.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
2
  13.3%
Male
13
  86.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Safety and Tolerability
Hide Description Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.
Time Frame During Treatment Phase average 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitomycin C With Hyperthermia
Hide Arm/Group Description:
Mitomycin C and Hyperthermia
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Hyperthermia Treatments
132
Measure Type: Number
Unit of Measure: Grade 1/2 event count (no grade 3+)
Abdominal pain 5
Fatigue 2
Myalgia 1
Heat intolerance 1
Urethral pain 6
Chemical cystitis 4
Hematuria 3
Bladder spasm 2
Weak urinary stream 1
Vaginitis 1
Nausea 2
Constipation 1
Swelling 4
Pruritis 3
Rash 2
Bruising 1
Flushing 1
Dizziness 2
Confusion 1
Anxiety 1
Extrapyramidal symptoms 1
Urinary Tract Infection 2
Hypertension 3
2.Secondary Outcome
Title Median Recurrence Free-survival
Hide Description Time to first recurrence of cancer in the bladder.
Time Frame Median follow-up 3.18 years
Hide Outcome Measure Data
Hide Analysis Population Description
Entire cohort
Arm/Group Title Hyperthermia System, Mitomycin C
Hide Arm/Group Description:

Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.

Hyperthermia System: Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence

Mitomycin C: 40 mg in 40 ml sterile water instilled into bladder

Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: Months
15.4 [1] 
(12.2 to NA)
[1]
Confidence interval not calculable due to insufficient number of participants.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mitomycin C With Hyperthermia
Hide Arm/Group Description Mitomycin C and Hyperthermia
All-Cause Mortality
Mitomycin C With Hyperthermia
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Mitomycin C With Hyperthermia
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mitomycin C With Hyperthermia
Affected / at Risk (%) # Events
Total   14/15 (93.33%)    
Blood and lymphatic system disorders   
Edema - localized  1  1/15 (6.67%)  1
Cardiac disorders   
Hypertension  1  3/15 (20.00%)  7
Gastrointestinal disorders   
Abdominal / pelvic discomfort * 1 [1]  6/15 (40.00%)  11
Nausea  1  1/15 (6.67%)  2
constipation  1/15 (6.67%)  1
General disorders   
Fatigue * 1  2/15 (13.33%)  3
Heat intolerance  1  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Myalgia * 1  1/15 (6.67%)  1
Nervous system disorders   
Confusion  1  1/15 (6.67%)  1
Dizziness * 1  2/15 (13.33%)  3
Extrapyramidal disorder  1  1/15 (6.67%)  1
Psychiatric disorders   
Anxiety  1/15 (6.67%)  1
Renal and urinary disorders   
Bladder spasms  1  2/15 (13.33%)  4
Cystitis  1  3/15 (20.00%)  4
Hematuria  1  3/15 (20.00%)  3
Urethral pain * 1  5/15 (33.33%)  8
Urinary Tract Infection - suspected  1  3/15 (20.00%)  3
Reproductive system and breast disorders   
Vaginitis  1 [2]  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Bruising  1  1/15 (6.67%)  1
Flushing  1  1/15 (6.67%)  1
Induration  1  3/15 (20.00%)  3
Pruritus * 1  3/15 (20.00%)  6
Rash  1  2/15 (13.33%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Complaint of discomfort during or post hyperthermia treatment
[2]
Not due to infection
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brant A. Inman, MD, MS
Organization: Duke University, Division of Urology
Phone: 919 684-1322
EMail: brant.inman@duke.edu
Layout table for additonal information
Responsible Party: Mark Dewhirst, Duke University
ClinicalTrials.gov Identifier: NCT00734994    
Other Study ID Numbers: Pro00003239
First Submitted: May 4, 2008
First Posted: August 14, 2008
Results First Submitted: August 1, 2011
Results First Posted: August 30, 2011
Last Update Posted: June 29, 2015