Trial Outcomes & Findings for Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer (NCT NCT00734994)
NCT ID: NCT00734994
Last Updated: 2015-06-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
15 participants
Primary outcome timeframe
During Treatment Phase average 6 weeks
Results posted on
2015-06-29
Participant Flow
Recruitment Period: 09/2008-09/2010 Location: Urology and Radiation Oncology Clinics
Participant milestones
| Measure |
Mitomycin C With Hyperthermia and Recurrent Bladder Cancer
Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Mitomycin C With Hyperthermia and Recurrent Bladder Cancer
Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer
Baseline characteristics by cohort
| Measure |
Mitomycin C With Hyperthermia
n=15 Participants
Mitomycin C and Hyperthermia
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During Treatment Phase average 6 weeksNumber 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.
Outcome measures
| Measure |
Hyperthermia System, Mitomycin C
n=132 Hyperthermia Treatments
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
|
|---|---|
|
Safety and Tolerability
Hypertension
|
3 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Abdominal pain
|
5 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Fatigue
|
2 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Myalgia
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Heat intolerance
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Urethral pain
|
6 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Chemical cystitis
|
4 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Hematuria
|
3 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Bladder spasm
|
2 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Weak urinary stream
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Vaginitis
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Nausea
|
2 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Constipation
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Swelling
|
4 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Pruritis
|
3 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Rash
|
2 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Bruising
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Flushing
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Dizziness
|
2 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Confusion
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Anxiety
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Extrapyramidal symptoms
|
1 Grade 1/2 event count (no grade 3+)
|
|
Safety and Tolerability
Urinary Tract Infection
|
2 Grade 1/2 event count (no grade 3+)
|
SECONDARY outcome
Timeframe: Median follow-up 3.18 yearsPopulation: Entire cohort
Time to first recurrence of cancer in the bladder.
Outcome measures
| Measure |
Hyperthermia System, Mitomycin C
n=15 Participants
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
|
|---|---|
|
Median Recurrence Free-survival
|
15.4 Months
Interval 12.2 to
Confidence interval not calculable due to insufficient number of participants.
|
Adverse Events
Mitomycin C With Hyperthermia
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mitomycin C With Hyperthermia
n=15 participants at risk
Mitomycin C and Hyperthermia
|
|---|---|
|
Gastrointestinal disorders
Abdominal / pelvic discomfort
|
40.0%
6/15 • Number of events 11
|
|
Renal and urinary disorders
Bladder spasms
|
13.3%
2/15 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Confusion
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
20.0%
3/15 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 3
|
|
Blood and lymphatic system disorders
Edema - localized
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Heat intolerance
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
20.0%
3/15 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
20.0%
3/15 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Induration
|
20.0%
3/15 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
3/15 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 3
|
|
Renal and urinary disorders
Urethral pain
|
33.3%
5/15 • Number of events 8
|
|
Renal and urinary disorders
Urinary Tract Infection - suspected
|
20.0%
3/15 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginitis
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1
|
Additional Information
Brant A. Inman, MD, MS
Duke University, Division of Urology
Phone: 919 684-1322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place