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Urinary Bladder CancerPhase 2NCT00462488

Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ

A Phase 2 study testing Vicinium in people with Urinary Bladder Cancer and Bladder Cancer, run by Sesen Bio, Inc. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vicinium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
21 sitesin 2 countries
Study dates
Mar 2007to Oct 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease Characteristics
  • The patient must be male or female 18 years of age or older.
  • The patient must have histologically-confirmed Transitional Cell Carcinoma (TCC) of the bladder.
  • The patient must have histologically-confirmed carcinoma in situ (CIS), with or without non-invasive papillary disease
  • The patient must have immunohistochemically-confirmed EpCAM positive disease.
  • The patient must have a life expectancy of at least 12 months.
Show all 14Show fewer
  • Prior/Concurrent Therapy
  • The patient must have, within the last 24 months, failed to respond to at least 1 cycle of treatment with BCG (with or without interferon) or be intolerant to BCG treatment.
  • The patient must have had a transurethral resection of the bladder tumour (TURBT) mapping the location of tumour and quantifying the area of bladder affected.
  • The patient must have documented residual CIS (i.e. unresectable disease) prior to study drug administration.
  • Patient Characteristics
  • The patient must have adequate organ function, as defined by the clinical trial protocol
  • Other
  • The patient must have the ability to understand and sign an Independent Ethics Committee or Institutional Review Board (IEC/IRB)- approved informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • The patient has evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging (i.e. intravenous pyelogram, computed tomography (CT) urogram, or retrograde pyelogram) within the past 2 years
  • The patient has hydronephrosis
  • The patient has had prior intravesical chemotherapy or investigational or anti-cancer treatments within the last 2 months, inclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT
  • The patient has existing severe urinary tract infection or recurrent severe bacterial cystitis
  • The patient has active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of intravesical therapy and/or general anesthesia
  • Any patient who, in the opinion of the investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders)
  • The patient is pregnant or breast feeding
  • Women of reproductive age (who are not either medically or surgically incapable or bearing children) and all men may not participate unless agreeing to use double barrier contraception, or commit to abstinence during the period of therapy

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Canada13 sites

  • The Male/Female Health and Research Centre, Royal Court Medical Centre

    Barrie, Ontario, L4M 7G1

  • Urology Resource Centre

    Burlington, Ontario, L7S 1V2

  • McMaster University, Institute of Urology at Saint Joseph's Hospital

    Hamilton, Ontario, L8N 4A6

  • Centre for Applied Urological Research

    Kingston, Ontario, K7L 2V7

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • The Fe/Male Health Centre

    Oakville, Ontario, L6H 3P1

  • Todd Webster, M.D.

    Owen Sound, Ontario, N4K 2J1

  • The Scarborough Hospital

    Scarborough Village, Ontario, M1P 2T7

  • Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont

    Sherbrooke, Quebec, J1H 5N4

  • Andreou Research

    Surrey, British Columbia, V3V 1N1

  • University of Toronto, Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Can-Med Clinical Research Inc.

    Victoria, British Columbia, V8T 5G9

Other trials in Canada

United States8 sites

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21287

  • Corpus Christi Urology Group, LLP

    Corpus Christi, Texas, 78404

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Lawrenceville Urology

    Lawrenceville, New Jersey, 08648

  • Grand Strand Urology

    Myrtle Beach, South Carolina, 29572

  • Urology of Virginia

    Newport News, Virginia, 23606

  • Oregon Urology Institute Research

    Springfield, Oregon, 97477

  • Southeastern Research Group, Inc.

    Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG)

The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).

Read the detailed description

A phase II study was performed to assess the efficacy and tolerability of intravesical Vicinium in patients with urothelial carcinoma in situ of the bladder. Bacillus Calmette-Guérin treatment had previously failed in all patients. A total of 46 patients were treated with Vicinium with half being administered 30mg/dose once per week for 6 weeks (cohort 1) and the other half (cohort 2) the same dose but administered once per week for 12 consecutive weeks. Disease assessments consisting of urine cytology, cystoscopy and, if indicated, biopsy were performed at 3 month intervals. Patients that were disease-free at the assessment time point were allowed to continue treatment in the maintenance phase which consisted of three weekly doses, followed by 9 weeks of no treatment. As long as the patient remained disease-free, treatment continued for a total of one year.

Being tested
Vicinium
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ViciniumDrug

    Also called VB4-845

    Intravesical administration of Vicinium

Study groups in NCT00462488
Study groupRoleWhat they receive
Treatment Schedule A -Active comparatorInduction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy. If the subject had histologically confirmed disease that is stage <T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study [EOS]).
Receives: Drug: Vicinium
Treatment Schedule BActive comparatorInduction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy. If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Receives: Drug: Vicinium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy

    Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment

    Measured: 12 or 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462488
Sponsor's protocol ID
VB4-845-02-IIA
Status last verified
Apr 2020
First submitted
17 Apr 2007
Last updated
12 May 2020
Data monitoring committee
No

Publications

  • Kowalski M, Guindon J, Brazas L, Moore C, Entwistle J, Cizeau J, Jewett MA, MacDonald GC. A phase II study of oportuzumab monatox: an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with bacillus Calmette-Guerin. J Urol. 2012 Nov;188(5):1712-8. doi: 10.1016/j.juro.2012.07.020. Epub 2012 Sep 19.

    PubMed 22998907

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vicinium in people with Urinary Bladder Cancer and Bladder Cancer, run by Sesen Bio, Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy (time frame: 12 or 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00462488, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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