Superficial Bladder Cancer Clinical Trial
Official title:
Pilot Study of External Hyperthermia and Intravesical Mitomycin-C To Treat Recurrent Bladder Cancer After Resection and Standard Adjuvant Therapy
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.
It is well established that tumor cells are sensitive to heat and when combined with a
chemotherapeutic agent, drug uptake and intracellular distribution of drug within malignant
cells is improved due to increased cellular permeability. Further, hyperthermia inhibits
deoxyribonucleic acid (DNA) repair as a result of increased reaction between DNA and
chemotherapy. By heating bladder tissue and accelerating the necessary series of reactions
to link agents such as mitomycin C to cell DNA, this effect may be optimized. Depending on
the extent of resection (and location, size, and depth of invasion of remaining tumor) after
transurethral resection of the bladder tumor(TURBT), recommended adjuvant therapy consists
of intravesical chemotherapy. MMC has been studied at doses as high as 80 mg without
producing significant or irreversible side effects. The most commonly used dose of mitomycin
is 40 mg.2
This pilot study proposes to use Mitomycin C at a dose of 40 mg in conjunction with deep
hyperthermia to enhance the effect intravesical chemotherapy as second-line treatment of
recurrent TCC (Stage Ta, T1, or Tis) of the bladder after surgical resection and standard
adjuvant therapy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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