Early Phase 1 Completed N=15 Treatment

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

Bladder Cancer

Source: ClinicalTrials.gov NCT00734994 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcomePrimary: Safety and Tolerability — 5; 2; 1; 1 Grade 1/2 event count (no grade 3+)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability	5; 2; 1; 1; 6; 4	—
SECONDARY Median Recurrence Free-survival	15.4	—

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

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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. Informational only — not medical advice.