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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mark Dewhirst
• Treatments: Mitomycin; Mitomycins

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