Early Phase 1
N=15
Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer
Transitional Cell Carcinoma of Bladder · Superficial Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00734994 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Safety and Tolerability — 5; 2; 1; 1 Grade 1/2 event count (no grade 3+)
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Hyperthermia System (Device); Mitomycin C (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mark Dewhirst
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability |
5; 2; 1; 1; 6; 4 | — |
| SECONDARY Median Recurrence Free-survival |
15.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00734994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.