BCG With or Without Mitomycin in Treating Patients With Bladder Cancer - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00023842

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer	Biological: BCG vaccine Drug: mitomycin C Procedure: adjuvant therapy Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Mitomycin BCG Vaccine Mitomycins

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 2001

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023842

Locations

Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, Belgium, B-8500
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Virga Jesse Hospital
Hasselt, Belgium, 3500
Italy
Azienda Ospedaliera Maggiore Della Carita
Novara, Italy, 28100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Universita Degli Studi Di Pisa
Pisa, Italy, 56126
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Portugal
Hospital Desterro
Amadora, Portugal, P-2700
Turkey
Dokuz Eylul University School of Medicine
Izmir, Turkey, 35340
United Kingdom, England
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
United Kingdom, Wales
University of Wales College of Medicine
Cardiff, Wales, United Kingdom, CF14 4XN

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Aldo V. Bono, MD

Ospedale di Circolo e Fondazione Macchi

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068869, EORTC-30993, AURO-EORTC-30993, FINNBLADDER-EORTC-30993, GAUO-EORTC-30993, SEUG-EORTC-30993, UKCCCR-EORTC-30993, NCRI-EORTC-30993
Study First Received:	September 13, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00023842 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

BCG Vaccine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urinary Bladder Diseases
Adjuvants, Immunologic
Urinary Bladder Neoplasms
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms

Antibiotics, Antineoplastic
Mitomycins
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Urologic Diseases
Therapeutic Uses
Mitomycin
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009