Content - SAKK 06/14

SAKK 06/14 - Treatment of recurrent bladder cancer

In 70-80% of patients with bladder cancer, the condition is diagnosed before the cancer cells have reached the muscle layer of the bladder (non-muscle invasive bladder cancer). In this situation, and once the tumour has been removed, it is possible to irrigate the bladder at regular intervals with something known as an immunomodulator – a medicinal product that promotes the body's natural defences against the cancer cells. This treatment lowers the risk of the cancer returning (a recurrence).

If it does recur, medical experts generally recommend surgery to remove the bladder. An additional treatment option for patients with recurrent bladder cancer is now being investigated in trial SAKK 06/14. The bladder of the study participants is irrigated once a week for several weeks with a new immunomodulator by the name of "VPM1002BC". This treatment option is suitable for patients who do not want to undergo surgery if their cancer recurs or for whom surgery would be too risky.

Study Chairs:

PhD Dr. med. Cyrill Rentsch, University Hospital Basel, +41 61 265 72 80

PhD Dr. med. Andreas Wicki, University Hospital Basel, +41 61 265 50 74

  • Contacts at the hospitals

  • Inclusion criteria

    • Histologically confirmed diagnosis of recurrent NMIBC (urothelial carcinoma) including repeat TURB confirming tumor-free state of the bladder (confirmed by TURB and biopsy) For patients with pure CIS of the bladder no repeat TURB is necessary.
    • Negative cytology before start of treatment, except for patients with concomitant CIS.
    • Planned treatment starts 2-5 weeks after last TURB
    • Pathological grading includes reporting according to WHO 1973 and 2004.
    • One previous cycle of intravesical BCG (induction phase with at least 5 instillations ± maintenance) not more than 5 years ago for NMIBC.
    • Patients have recurrent high-risk NMIBC for progression.
  • Exclusion criteria

    • Current or previous ≥ T2 urothelial carcinoma (UC) of the urinary bladder
    • Bladder surgery or traumatic catheterization or TURB within 2 weeks prior to the expected start of trial treatment
    • Stress urinary incontinence >I°, severe urge or urge urinary incontinence preventing the patient to keep the IMP in the bladder for at least 1 hour. Residual urinary bladder volume after micturition is > 150 ml.
    • Active concomitant malignant conditions except basal cell skin carcinoma and cervical carcinoma in situ. History of malignancy in the last 3 years except previous NMIBC.
    • Primary or secondary immunodeficiencies
    • Positive HIV test
    • Chronic administration (defined as more than 14 consecutive days) of immunosuppressive drugs or other immune modifying drugs within three months before instillation
    • Uncontrollable urinary tract infection, macroscopic haematuria, suspicion of bladder perforation, urethral strictures (if interfering with trial procedures)
    • Current and past pelvic radiation and brachytherapy
    • Active tuberculosis or other ongoing mycobacterial infection.
    • History of anaphylaxis or severe allergic reactions, known allergies to any component of the investigational product, BCG intolerance
    • Local and severe allergy (e.g. ulceration, systemic reactions) to PPD test
    • Acute fever or fever (>38.5˚C) in the last 7 days before registration
    • Simultaneous administration of antituberculous agents and antibiotics that cannot be stopped until registration

Locations for this trial:

Kantonsspital Aarau
Tellstrasse 25
0 5001 Aarau
Kantonsspital Baden
Im Ergel 1
4600 Baden
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Freiburgstrasse 8
3010 Bern
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Centre Hospitalier Universitaire Vaudois CHUV
Rue du Bugnon 46
0 Lausanne
Fondazione Oncologia Lago Maggiore
Via Antonio Ciseri 19
0 6600 Locarno
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Uniklinik Regensburg
Franz-Josef-Strauß-Allee 11
0 93053 Regensburg
Ruhr-Universität Bochum
Universitätsstrasse 150
0 44801 Bochum
Universitätsklinikum Freiburg
Hugstetter Str. 55
0 79106 Freiburg im Breisgau
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Langenbeckstrasse 1
0 55131 Mainz
Universitätsklinikum Jena
Bachstraße 18
0 07743 Jena
Klinikum Nürnberg
Prof.-Ernst-Nathan-Str. 1
0 90419 Nürnberg