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

Completed · Early Phase 1

Conditions studied: Transitional Cell Carcinoma of Bladder, Superficial Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00734994

Run by

Mark Dewhirst

People needed

15

Starts

2008-04-01

Expected to finish

2011-03-01

Last updated by the study team

2015-06-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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