BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00023842
First received: September 13, 2001
Last updated: September 20, 2012
Last verified: September 2012
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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 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
| Enrollment: | 97 |
| Study Start Date: | June 2001 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
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 | |
| 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 | |
| Italy | |
| 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 | |
| Netherlands | |
| 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 | |
| Portugal | |
| Hospital Desterro | |
| Amadora, Portugal, P-2700 | |
| Turkey | |
| Dokuz Eylul University School of Medicine | |
| Izmir, Turkey, 35340 | |
| United Kingdom | |
| Bristol Royal Infirmary | |
| Bristol, England, United Kingdom, BS2 8HW | |
| University of Wales College of Medicine | |
| Cardiff, Wales, United Kingdom, CF14 4XN | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Aldo V. Bono, MD | Ospedale di Circolo e Fondazione Macchi |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00023842 History of Changes |
| Other Study ID Numbers: | EORTC-30993, 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: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage 0 bladder cancer recurrent bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma in Situ Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Mitomycins Mitomycin |
BCG Vaccine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013