Status:
COMPLETED
Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer
Lead Sponsor:
Mark Dewhirst
Conditions:
Transitional Cell Carcinoma of Bladder
Superficial Bladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 r...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00734994
Start Date
April 1 2008
End Date
March 1 2011
Last Update
June 29 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710