Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer:

1. A combination of bladder wall heating and local chemotherapy (Synergo)

2. Bacillus Calmette-Guérin (BCG)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Enterprises Europe B.V.
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Superficial TCC: Any G3 or any T1 and/or CIS

• Multifocal (>1) Ta lesions

• Multiple recurrences (>2) of Ta lesions in the last 24 months

• Complete tumor eradication must be confirmed

• WHO performance status 0-2 (Appendix V)

• Life expectancy of more than 24 months

• Patients willing to sign informed consent

Exclusion Criteria:

• Bladder tumors other than TCC

• Coexistence of another primary malignant tumor other than BCC of the skin

• TCC of the bladder involving the urethra or upper urinary tract

• Previous history of TCC stage T2 or higher

• Clinical presence or previous history of regional spreading or distant metastases

• Intravesical MMC treatments during the last 12 months

• Previous intravesical BCG therapy (Any intravesical BCG therapy in the last 24 months, or More than 6 BCG intravesical instillations in the last 48 months.

• Previous pelvic radiotherapy or systemic chemotherapy

• Partial cystectomy

• Diverticle of bladder larger than 1cm in diameter

• Residual urine > 100cc measured by uroflowmetry

• Bladder volume < 150cc measured by ultrasound

• Urinary incontinence (more than one wet pad a day)

• Urethral stricture impeding 20F catheterization

• Urethral bleeding or persistent hematuria

• Active intractable or uncontrollable UTI

• Active tuberculosis or BCG infection

• Patients who experienced BCG life threatening sepsis

• Known allergy to MMC or BCG

• Known impaired immune response, positive HIV serology, patients receiving systemic steroids or immunosuppressive therapy

• Hematological disorders; leukocytes < 3500, platelets < 100,000

• Kidney or liver function disorders (more than 1.5 times upper normal limit)

• Pregnant or lactating women

• Patients who cannot be followed up properly or are unable to collaborate