BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
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.
Biological: BCG vaccine
Drug: mitomycin C
Procedure: adjuvant therapy
Procedure: conventional surgery
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder|
|Study Start Date:||June 2001|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
- 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.
- 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.
- 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.
|Onze Lieve Vrouw Ziekenhuis Aalst|
|Aalst, Belgium, B-9300|
|Academisch Ziekenhuis der Vrije Universiteit Brussel|
|Brussels, Belgium, 1090|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Virga Jesse Hospital|
|Hasselt, Belgium, 3500|
|Cazk Groeninghe - Campus Maria's Voorzienigheid|
|Kortrijk, Belgium, B-8500|
|Azienda Ospedaliera Maggiore Della Carita|
|Novara, Italy, 28100|
|Universita Degli Studi Di Pisa|
|Pisa, Italy, 56126|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Amadora, Portugal, P-2700|
|Dokuz Eylul University School of Medicine|
|Izmir, Turkey, 35340|
|Bristol Royal Infirmary|
|Bristol, England, United Kingdom, BS2 8HW|
|University of Wales College of Medicine|
|Cardiff, Wales, United Kingdom, CF14 4XN|
|Study Chair:||Aldo V. Bono, MD||Ospedale di Circolo e Fondazione Macchi|