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

Neoplasms Clinical Trial

Official title:

A Randomized Controlled Study Comparing Adjuvant Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG Immunotherapy (BCG) Adjuvant Treatment in Patients With Superficial Transitional Cell Carcinoma of the Bladder (STCCB)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384891
• Other study ID #: 102.1
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2006
• Last updated: October 5, 2014
• Start date: February 2002
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Medical Enterprises Europe B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

Description:

The study is a randomized controlled study, designed to test the efficacy and safety of a new treatment modality for the prevention of tumor recurrence in superficial bladder cancer.

Patients must have their tumors surgically resected prior to study enrollment, and undergo a series of tests to prove their bladder is now free of tumor. Eligible patients will be randomly assigned to one of 2 treatment arms:

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

2. Bacillus Calmette-Guérin (BCG)

Patients will be treated during the first year of the study, and will be followed up for a total of 2 years. The follow up will include a visual evaluation of the patient's bladder by cystoscopy, a cytological examination of the urine (to look for malignant cells) and other additional exams. The patients' general welfare will be monitored through out the study.

The aim of this study is to compare the efficacy and safety of the novel treatment (Synergo) to that of the well-known BCG

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Malignant Tumor of Urinary Bladder
• Neoplasms
• Neoplasms by Site
• Urinary Bladder Cancer
• Urinary Bladder Diseases
• Urinary Bladder Neoplasms
• Urologic Diseases
• Urologic Neoplasms

Intervention

Device:
• Synergo + MMC
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C

Drug:
• Bacillus Calmette-Guérin
Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Locations

Country	Name	City	State
Austria	University Hospital - AKH Vienna	Vienna
Israel	Bnai Zion Medical Center	Haifa
Israel	Wolfson Hospital	Holon
Israel	Hadassah University Hospital	Jerusalem
Italy	Galliera Hospital	Genova
Italy	Istituto Europeo del Oncologia	Milan
Italy	San Raffaele Hospital (HSR)	Milan
Netherlands	Department of Urology, Radboud University Hospital	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Medical Enterprises Europe B.V.

Countries where clinical trial is conducted

Austria,  Israel,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival	Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor	2 years	No
Secondary	Proportion of complete response in CIS patients		3 months	No
Secondary	Progression rate (to disease stage>T1) and/or metastatic disease		2 years	No
Secondary	Local and systemic side effects, both subjective and objective		2 years	Yes