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

Launched by MARK DEWHIRST · Aug 13, 2008

Keywords

ClinConnect Summary

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 inva...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Non-muscle invasive transitional cell carcinoma (TCC) of the bladder (Ta, T1, Tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with Bacillus Calmette Guerin (BCG) solution); or
• • An inability to tolerate BCG
• • Age \> 18
• • Eastern Cooperative Oncology Group(ECOG) Performance Status 0-2
• * Laboratory tests performed within 14 days of study enrollment:
• • Leukocytes ≥ 3,200, Absolute Neutrophil count ≥ 1,500, Platelets ≥ 100,000
• • Hemoglobin ≥ 9.0 gm/dL, Total bilirubin ≤ institution upper limit of normal \*(ULN), Asparate Aminotransferase(AST) and Alanine Aminotransferase(ALT) ≤ 2.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN
• • Creatinine ≤ 1.5 times ULN
• • Women of child bearing potential must have a negative pregnancy test
• • If post-menopausal - Amenorrhea for ≥ 12 months
• Exclusion Criteria:
• • Pregnancy or breastfeeding
• • Muscle invasive disease (T2-T4)
• • Prior radiation to the pelvis
• • Peripheral neuropathy (any grade)
• • Thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes
• • Known bladder fistula
• • Hypersensitive or idiosyncratic reaction to mitomycin-C or its components in the past