Clinical trial · Interventional
Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer
Pilot Study of External Hyperthermia and Intravesical Mitomycin-C To Treat Recurrent Bladder Cancer After Resection and Standard Adjuvant Therapy
NCT00734994CI-TRIAL-00018396completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Superficial Bladder Cancer | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| Transitional Cell Carcinoma of Bladder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia System | Device | — | UNRESOLVED |
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperthermia system, Mitomycin C
- description
- Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.
- interventionNames
- Device: Hyperthermia System
- Drug: Mitomycin C
Primary outcomes (1)
- measure
- Safety and Tolerability
- timeFrame
- During Treatment Phase average 6 weeks
- description
- Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDJuang T, Stauffer PR, Craciunescu OA, Maccarini PF, Yuan Y, Das SK, Dewhirst MW, Inman BA, Vujaskovic Z. Thermal dosimetry characteristics of deep regional heating of non-muscle invasive bladder cancer. Int J Hyperthermia. 2014 May;30(3):176-83. doi: 10.3109/02656736.2014.898338. Epub 2014 Mar 26. PMID 24669804
- BACKGROUNDYuan Y, Cheng KS, Craciunescu OI, Stauffer PR, Maccarini PF, Arunachalam K, Vujaskovic Z, Dewhirst MW, Das SK. Utility of treatment planning for thermochemotherapy treatment of nonmuscle invasive bladder carcinoma. Med Phys. 2012 Mar;39(3):1170-81. doi: 10.1118/1.3679839. PMID 22380348
- RESULTInman BA, Stauffer PR, Craciunescu OA, Maccarini PF, Dewhirst MW, Vujaskovic Z. A pilot clinical trial of intravesical mitomycin-C and external deep pelvic hyperthermia for non-muscle-invasive bladder cancer. Int J Hyperthermia. 2014 May;30(3):171-5. doi: 10.3109/02656736.2014.882021. Epub 2014 Feb 3. PMID 24490762