CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 15 enrolled
Drug / intervention
Mitomycin C +1 moredrug
Likely dose
Mitomycin C 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00734994
NCT00734994Early Ph 1Completed
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Pilot Study of External Hyperthermia and Intravesical Mitomycin-C To Treat Recurrent Bladder Cancer After Resection and Standard Adjuvant Therapy

Mark Dewhirst·interventional·Posted Aug 14, 2008·Updated Jun 29, 2015

In Brief

A Early Phase 1 clinical trial evaluating Hyperthermia System and Mitomycin C for Transitional Cell Carcinoma of Bladder and Superficial Bladder Cancer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Hypothesis: In selected patients external hyperthermia will be used in combination with intravesical Mitomycin-C (MMC) to treat recurrent transitional cell carcinoma (TCC) of the bladder after local resection and standard adjuvant therapy and thus prevent or delay recurrence and the need for radical cystectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransitional Cell Carcinoma of Bladder, Superficial Bladder Cancer
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

Hyperthermia Systemdevice

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 Cdrug

40 mg in 40 ml sterile water instilled into bladder