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VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02371447
Recruitment Status : Active, not recruiting
First Posted : February 25, 2015
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

This phase I/II trial will assess the safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of VPM1002BC will be compared to results previously reported for BCG in a similar population. The quality of life will be also investigated as a secondary endpoint. Additional immunology assessments are foreseen as exploratory analyses to investigate the immunogenicity of VPM1002BC.

The Phase II of the trial has been opened on 27.07.2016.


Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: VPM1002BC Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open Label Clinical Trial Assessing Safety and Efficacy of Intravesical Instillation of VPM1002BC in Patients With Recurrent Non-muscle Invasive Bladder Cancer After Standard BCG Therapy
Actual Study Start Date : September 8, 2015
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: VPM1002BC Induction

Phase 1:

Induction: 6 intravesical instillations of VPM1002BC in 6-12 weeks (dose de-escalation in cohorts of 3-6 patients)

Phase 2:

Induction: VPM1002BC at RP2D established in phase I, 6 intravesical instillations in 6-12 weeks (n=39 including patients treated at RPD2 in phase I)

Maintenance: 3 instillations of VPM1002BC at months 3, 6 and 12

Drug: VPM1002BC

Phase 1:

Induction: 6 intravesical instillations of VPM1002BC in 6-12 weeks (dose de-escalation in cohorts of 3-6 patients)

Phase 2:

Induction: VPM1002BC at RP2D established in phase I, 6 intravesical instillations in 6-12 weeks (n=39 including patients treated at RPD2 in phase I)

Other Names:
  • Mycobacterium bovis BCG∆ureC::Hly+
  • VPM1002




Primary Outcome Measures :
  1. Phase 1: Dose limiting toxicity (DLT) of intravesical VPM1002BC instillations in patients with recurrence after standard BCG therapy in non-muscle-invasive bladder cancer. [ Time Frame: within 5 weeks ]
    Adverse events grade 3 and 4 related to the trial treatment

  2. Phase 2: Recurrence-free rate in the bladder [ Time Frame: at 60 weeks ]
    No visual evidence of cancer in the bladder and negative cytology.


Secondary Outcome Measures :
  1. Time to recurrence in the bladder (from registration to tumor recurrence in the bladder) [ Time Frame: within 60 weeks ]
  2. Time to recurrence (from registration to recurrence at local, regional or distant site) [ Time Frame: within 60 weeks ]
  3. Time to progression (from registration to progression). [ Time Frame: within 60 weeks ]
    Progression is defined as a recurrence with an increased stage or grade.

  4. Overall survival calculated from registration until death from any cause [ Time Frame: from registration until death (within 6 years) ]
  5. Adverse events assessed according to NCI CTCAE v4.0. [ Time Frame: within 60 weeks ]
    from registration until 12 weeks after last instillation for patients not completing the overall treatment or after week 60 for patients completing the entire maintenance phase.

  6. Quality of Life assessed by questionnaires [ Time Frame: within 60 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 low risk prostate cancer qualifying for active surveillance according to PRIAS criteria (http://www.prostatecancer-riskcalculator.com/active-surveillance-and-prias-study), 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

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): NCT02371447


Locations
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Germany
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Universitätsklinikum der Ruhr-Universität Bochum
Herne, Germany, 44625
Universitätsklinikum Jena
Jena, Germany, 07747
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Klinikum Nürnberg - Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nürnberg, Germany, 90419
Uniklinik Regensburg
Regensburg, Germany, 93053
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
Kantonsspital Baden
Baden, Switzerland, 5404
Universitaetsspital-Basel
Basel, Switzerland, 4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
Inselspital, Bern
Bern, Switzerland, 3010
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Hôpitaux Universitaires de Genève
Genève 14, Switzerland, 1211
Centre hospitalier universitaire vaudois CHUV
Lausanne, Switzerland, 1011
Fondazione Oncologia Lago Maggiore
Locarno, Switzerland, 6600
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Cyrill Rentsch, MD, PhD University Hospital, Basel, Switzerland
Study Chair: Andreas Wicki, MD, PhD University Hospital, Basel, Switzerland

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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT02371447     History of Changes
Other Study ID Numbers: SAKK 06/14
SNCTP000001181 ( Other Identifier: SNCTP )
2014-005330-58 ( EudraCT Number )
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Swiss Group for Clinical Cancer Research:
bladder cancer
recurrent non-muscle invasive bladder cancer
VPM1002BC
BCG therapy

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases