BCG With or Without Mitomycin in Treating Patients With Bladder Cancer

NCT00023842 | Completed Phase 2

• 7 other identifiers: EORTC-30993AURO-EORTC-30993FINNBLADDER-EORTC-30993GAUO-EORTC-30993SEUG-EORTC-30993UKCCCR-EORTC-30993NCRI-EORTC-30993
• Study Type: interventional
• Target: 97
• Locations: 6 countries
• Sites: 16

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

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

Interventions

BCG vaccine BIOLOGICAL

mitomycin C DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (16)

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

Azienda Ospedaliera Maggiore Della Carita

Novara, 28100, Italy

Location

Universita Degli Studi Di Pisa

Pisa, 56126, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Hospital Desterro

Amadora, P-2700, Portugal

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

Bristol Royal Infirmary

Bristol, England, BS2 8HW, United Kingdom

Location

University of Wales College of Medicine

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21156335 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

BCG Vaccine; Mitomycin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Aldo V. Bono, MD

  Ospedale di Circolo e Fondazione Macchi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Primary Completion: February 1, 2005
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

TU (1); NL (4); PT (1); GB (2); IT (3); BE (5)