BCG With or Without Mitomycin in Treating Patients With Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Brief Summary

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RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological therapy may kill more tumor cells. It is not yet known if BCG is more effective with or without mitomycin.

PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer.

Detailed Description

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OBJECTIVES:

* Compare the complete response rate of patients with carcinoma in situ of the bladder treated with adjuvant intravesical BCG with or without intravesical mitomycin following transurethral resection.
* Compare the disease-free interval and type of recurrence after complete response in patients treated with these regimens.
* Compare the side effects of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.

Arm I:

* Induction therapy: Patients receive intravesical mitomycin over 1 hour once weekly on weeks 1-6 and intravesical BCG once weekly on weeks 7-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy.
* Maintenance therapy:Patients with a complete response after either course of induction therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1 and intravesical BCG once weekly on weeks 2 and 3. Maintenance therapy repeats every 6 months through year 3.

Arm II:

* Induction therapy:Patients receive intravesical BCG once weekly on weeks 1-6 and 10-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy.
* Maintenance therapy: Patients with a complete response after either course of induction therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks 1-3. Maintenance therapy repeats every 6 months through year 3.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-126 patients (42-63 per treatment arm) will be accrued for this study within 3.5 years.

Conditions

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Bladder Cancer

Keywords

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stage 0 bladder cancer recurrent bladder cancer transitional cell carcinoma of the bladder

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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BCG vaccine

Intervention Type BIOLOGICAL

mitomycin C

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed carcinoma in situ (CIS) of the bladder with urinary cytology

* Primary CIS (no prior history of CIS, papillary, or solid transitional cell carcinoma \[TCC\] of the bladder and no concurrent papillary or solid TCC) OR
* Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the bladder) OR
* Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of the bladder)
* No more than 28 days since prior transurethral resection (TUR) of all visible lesions
* No muscle involvement
* No prior or concurrent upper urinary tract tumors
* No urethral strictures that would prevent endoscopic procedures and repeated catheterization
* No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risky

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* No active tuberculosis (highly positive skin tests allowed if no active disease)
* No disease that would preclude general anesthesia
* No active intractable or uncontrollable infection
* No other prior or concurrent malignancy except cured basal cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior BCG

Chemotherapy:

* More than 3 months since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to the pelvis

Surgery:

* See Disease Characteristics

Other:

* More than 3 months since prior intravesical cytostatic agents

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aldo V. Bono, MD

Role: STUDY_CHAIR

Ospedale di Circolo e Fondazione Macchi

Locations

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Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, , Belgium

Site Status

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Virga Jesse Hospital

Hasselt, , Belgium

Site Status

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, , Belgium

Site Status

Azienda Ospedaliera Maggiore Della Carita

Novara, , Italy

Site Status

Universita Degli Studi Di Pisa

Pisa, , Italy

Site Status

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

University Medical Center Nijmegen

Nijmegen, , Netherlands

Site Status

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Hospital Desterro

Amadora, , Portugal

Site Status

Dokuz Eylul University School of Medicine

Izmir, , Turkey (Türkiye)

Site Status

Bristol Royal Infirmary

Bristol, England, United Kingdom

Site Status

University of Wales College of Medicine

Cardiff, Wales, United Kingdom

Site Status

Countries

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Belgium Italy Netherlands Portugal Turkey (Türkiye) United Kingdom

References

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Oosterlinck W, Kirkali Z, Sylvester R, da Silva FC, Busch C, Algaba F, Collette S, Bono A. Sequential intravesical chemoimmunotherapy with mitomycin C and bacillus Calmette-Guerin and with bacillus Calmette-Guerin alone in patients with carcinoma in situ of the urinary bladder: results of an EORTC genito-urinary group randomized phase 2 trial (30993). Eur Urol. 2011 Mar;59(3):438-46. doi: 10.1016/j.eururo.2010.11.038. Epub 2010 Dec 7.

Reference Type RESULT

PMID: 21156335 (View on PubMed)