Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "Bladder Squamous Cell Carcinoma" | "Adjuvants, Immunologic"
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Disease-free survival time
  2. Complete response rate at 3 months in patients with carcinoma in situ

Secondary Outcome Measures :
  1. Recurrence-free survival time
  2. Progression-free survival time
  3. Overall survival time
  4. Disease-specific survival time
  5. Safety and tolerability
  6. Quality of Life
  7. Cost effectiveness
  8. Biomarkers of response to standard and investigational treatment


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-muscle invasive bladder cancer
  • Recurrent disease after undergoing induction or maintenance therapy with bacillus Calmette-Guérin (BCG), meeting any 1 of the following criteria:

    • Stage Ta or T1 disease (grade 2 or 3)
    • Carcinoma in situ with stage Ta or T1 disease (grade 1, 2, or 3)
    • Carcinoma in situ alone
  • Has undergone a second resection of all T1 disease to exclude muscle invasive disease
  • No urothelial cell carcinoma (UCC) ≥ T2
  • No recurrence of grade 1 UCC following BCG induction therapy
  • No UCC involving the prostatic urethra or upper urinary tract

PATIENT CHARACTERISTICS:

  • WHO performance status 0-4
  • WBC ≥ 3.0 x 10^9/L
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Hemoglobin ≥ 10 g/dL
  • Platelet count ≥ 100 x 10^9/L
  • Serum creatinine < 1.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Normal kidneys and ureters on imaging CT scan within the past 12 months
  • Available for long-term follow-up with a life expectancy of the duration of the trial
  • Must be fit and willing to undergo a full or partial cystectomy
  • No known or suspected reduced bladder capacity (< 250 mL)
  • No significant bleeding disorder
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, or DCIS/LCIS of the breast
  • No known allergy to mitomycin or bacillus Calmette-Guérin (BCG), or previously withdrawn from BCG treatment due to a related adverse event (e.g., systemic infection)
  • No active or intractable urinary tract infection
  • No urethral stricture or any situation impeding the insertion of a 20F catheter
  • No bladder diverticula > 1 cm
  • No significant urinary incontinence
  • No concurrent implanted electronic devices (e.g., cardiac pacemakers) or metallic implants within the pelvis, lower torso, spine, hip, or upper femur
  • No immunocompromised state for any reason

PRIOR CONCURRENT THERAPY:

  • At least 6 months since prior intravesical chemotherapy, except for single instillation post-transurethral resection
  • No prior pelvic irradiation
  • No prior hyperthermia in combination with intravesical mitomycin
  • Concurrent participation in other studies allowed
  • No current or long-term use of corticosteroids
  • No concurrent chemotherapy

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
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      
Sponsors and Collaborators
Cancer Research Campaign Clinical Trials Centre
Investigators
Layout table for investigator information
Principal Investigator: John Kelly, MD University College London Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT01094964     History of Changes
Other Study ID Numbers: CRC-TU-BL3010-HYMN
CDR0000668528 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN85785327
EUDRACT-2008-005428-99
EU-21015
UCL-08/0365
KYOWA-CRC-TU-BL3010-HYMN
MREC-09/H0717/56
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: March 2010
Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
stage 0 bladder cancer
stage I bladder cancer
adenocarcinoma of the bladder
squamous cell carcinoma of the bladder
Additional relevant MeSH terms:
Layout table for MeSH terms
Adjuvants, Immunologic
Urinary Bladder Neoplasms
Fever
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Body Temperature Changes
Signs and Symptoms
Interferons
Interferon-alpha
Epirubicin
Mitomycins
Mitomycin
BCG Vaccine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Nucleic Acid Synthesis Inhibitors