Hyperthermia and Mitomycin C, Bacillus Calmette-Guerin, or Standard Therapy as Second-Line Therapy in Treating Patients With Recurrent Bladder Cancer

NCT01094964 | Unknown Phase 3

• 8 other identifiers: CRC-TU-BL3010-HYMNCDR0000668528ISRCTN85785327EUDRACT-2008-005428-99EU-21015UCL-08/0365KYOWA-CRC-TU-BL3010-HYMNMREC-09/H0717/56
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 9

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.

Conditions

Bladder Cancer

Keywords

recurrent bladder cancer; stage 0 bladder cancer; stage I bladder cancer; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (2)

• Disease-free survival time

• Complete response rate at 3 months in patients with carcinoma in situ

Secondary Outcomes (8)

• Recurrence-free survival time

• Progression-free survival time

• Overall survival time

• Disease-specific survival time

• Safety and tolerability

Interventions

BCG solution BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

epirubicin hydrochloride DRUG

mitomycin C DRUG

laboratory biomarker analysis OTHER

hyperthermia treatment PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research Campaign Clinical Trials Centre: lead

Study Sites (9)

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

RECRUITING

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

St. George's Hospital

London, England, SW17 0QT, United Kingdom

RECRUITING

University College of London Hospitals

London, England, WC1E 6AU, United Kingdom

RECRUITING

South Manchester University Hospital

Manchester, England, M20 2LR, United Kingdom

RECRUITING

James Cook University Hospital

Middlesbrough, England, TS19 8PE, United Kingdom

RECRUITING

University Hospital of Wales

Cardiff, Wales, CF14 4XN, United Kingdom

RECRUITING

Related Publications (1)

• Tan WS, Panchal A, Buckley L, Devall AJ, Loubiere LS, Pope AM, Feneley MR, Cresswell J, Issa R, Mostafid H, Madaan S, Bhatt R, McGrath J, Sangar V, Griffiths TRL, Page T, Hodgson D, Datta SN, Billingham LJ, Kelly JD. Radiofrequency-induced Thermo-chemotherapy Effect Versus a Second Course of Bacillus Calmette-Guerin or Institutional Standard in Patients with Recurrence of Non-muscle-invasive Bladder Cancer Following Induction or Maintenance Bacillus Calmette-Guerin Therapy (HYMN): A Phase III, Open-label, Randomised Controlled Trial. Eur Urol. 2019 Jan;75(1):63-71. doi: 10.1016/j.eururo.2018.09.005. Epub 2018 Sep 28.

  PMID: 30274699 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Interferon-alpha; Epirubicin; Mitomycin; Diathermy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Mitomycins; Indolequinones; Quinones; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hyperthermia, Induced; Therapeutics

Study Officials

• John Kelly, MD

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 29, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2013
• Last Updated: August 12, 2013

Record last verified: 2010-03

Locations

GB (9)