Expired Study
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Durham, North Carolina 27710


Purpose:

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


Criteria:

Inclusion Criteria: - Non-muscle invasive 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 BCG solution); or - An inability to tolerate BCG - Age > 18 - 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), AST and 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


NCT ID:

NCT00734994


Primary Contact:

Principal Investigator
Zeljko Vujaskovic, MD, PhD
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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