Hyperthermia and Mitomycin C, Bacillus Calmette-Guerin, or Standard Therapy as Second-Line Therapy in Treating Patients With Recurrent Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01094964|
Recruitment Status : Unknown
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 29, 2010
Last Update Posted : August 12, 2013
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Drugs used in chemotherapy, such as mitomycin C and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as bacillus calmette-guerin (BCG) and interferon alfa, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether giving hyperthermia together with mitomycin C is more effective than giving BCG or standard therapy as second-line therapy in treating patients with recurrent bladder cancer.
PURPOSE: This randomized phase III trial is studying how well hyperthermia given together with mitomycin C works compared with BCG or standard therapy as second-line therapy in treating patients with recurrent bladder cancer.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Biological: BCG solution Biological: recombinant interferon alfa Drug: epirubicin hydrochloride Drug: mitomycin C Other: laboratory biomarker analysis Procedure: hyperthermia treatment Procedure: quality-of-life assessment||Phase 3|
- To determine whether hyperthermia in combination with mitomycin C versus bacillus Calmette-Guerin (BCG) or standard therapy as second-line therapy is effective in patients with recurrent non-muscle invasive bladder cancer following induction or maintenance therapy with BCG.
- To compare disease-free survival time in all patients.
- To compare complete response rate at 3 months in patients with carcinoma in situ.
- To compare progression-free survival, overall survival, safety and tolerability of treatments, quality of life, cost, and cost-effectiveness in these patients.
- To assess biomarkers of response to standard and investigational treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of carcinoma in situ (yes vs no), prior bacillus Calmette-Guérin (BCG) therapy (induction vs maintenance), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (experimental): Patients receive intravesical mitomycin C over two 30-minute instillations per session, and bladder hyperthermia (42 +/-2°C) is delivered in combination with each instillation. The suspension is maintained in the bladder for up to 2 hours. Treatment repeats once a week for 6 weeks followed by a 6-week rest period. Patients who are disease-free proceed to maintenance therapy consisting of one instillation of mitomycin C with bladder hyperthermia every 6 weeks for 1 year and then once every 8 weeks for 1 year. Patients who are disease-free at 24 months may continue treatment at the discretion of the clinician.
Arm II (control): Patients receive 1 of the following treatment regimens depending on prior BCG treatment.
- Second course of BCG therapy (patients who failed previous induction BCG): Patients receive intravesical BCG (1 instillation) once a week for 6 weeks. The suspension is maintained in the bladder for up to 2 hours. Patients then receive maintenance therapy consisting of BCG once a week for 3 weeks in months 3, 6, 12, 18, and 24. Patients who are disease-free at 24 months may continue treatment at the discretion of the clinician.
- Standard therapy (patients who failed previous maintenance BCG): Patients receive standard therapy for BCG failure as defined by their treating centers. Standard therapy may include intravesical BCG alone, intravesical mitomycin C alone, intravesical epirubicin hydrochloride alone, or intravesical BCG in combination with interferon alpha.
All patients undergo cystoscopic surveillance with or without a biopsy every 3 months for 2 years. Urine, blood, and tissue samples are collected periodically for biomarker laboratory studies. Patients complete quality of life questionnaires (EORTC QLQ-BLS24, QLQ-C30, and EQ5D) at baseline, at 12 weeks, and at 6, 9, and 12 months.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||242 participants|
|Masking:||None (Open Label)|
|Official Title:||HYMN: A Randomized Controlled Phase III Trial Comparing Hyperthermia Plus Mitomycin to a Second Course of Bacillus Calmette-Guerin or Standard Therapy in Patients With Recurrence of Non-Muscle Invasive Bladder Cancer Following Induction or Maintenance Bacillus Calmette-Guerin Therapy|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||October 2013|
- Disease-free survival time
- Complete response rate at 3 months in patients with carcinoma in situ
- Recurrence-free survival time
- Progression-free survival time
- Overall survival time
- Disease-specific survival time
- Safety and tolerability
- Quality of Life
- Cost effectiveness
- Biomarkers of response to standard and investigational treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094964
|Basingstoke and North Hampshire NHS Foundation Trust||Recruiting|
|Basingstoke, England, United Kingdom, RG24 9NA|
|Contact: Contact Person 44-1256-314-700|
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust||Recruiting|
|Birmingham, England, United Kingdom, B15 2TH|
|Contact: Contact Person 44-121-472-1311|
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Contact Person 44-113-243-3144|
|University Hospitals of Leicester NHS Trust||Recruiting|
|Leicester, England, United Kingdom, LE1 5WW|
|Contact: Contact Person 44-300-303-1573|
|St. George's Hospital||Recruiting|
|London, England, United Kingdom, SW17 0QT|
|Contact: Contact Person 44-208-672-1255|
|University College of London Hospitals||Recruiting|
|London, England, United Kingdom, WC1E 6AU|
|Contact: Contact Person 44-845-1555-000|
|South Manchester University Hospital||Recruiting|
|Manchester, England, United Kingdom, M20 2LR|
|Contact: Contact Person 44-161-998-7070|
|James Cook University Hospital||Recruiting|
|Middlesbrough, England, United Kingdom, TS19 8PE|
|Contact: Contact Person 44-1609-779-911|
|University Hospital of Wales||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 4XN|
|Contact: Contact Person 44-29-2074-7747|
|Principal Investigator:||John Kelly, MD||University College London Hospitals|