NCT00462488

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
10.6 years until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

April 17, 2007

Results QC Date

September 4, 2019

Last Update Submit

April 30, 2020

Conditions

Urinary Bladder CancerBladder CancerBladder NeoplasmsBladder Tumors

Outcome Measures

Primary Outcomes (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

    12 or 13 weeks

Study Arms (2)

Treatment Schedule A -

ACTIVE COMPARATOR

Induction 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 \[EOS\]).

Drug: Vicinium

Treatment Schedule B

ACTIVE COMPARATOR

Induction 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).

Drug: Vicinium

Interventions

ViciniumDRUG

Intravesical administration of Vicinium

Also known as: VB4-845
Treatment Schedule A -Treatment Schedule B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Southeastern Research Group, Inc.

Tallahassee, Florida, 32308, United States

Location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Lawrenceville Urology

Lawrenceville, New Jersey, 08648, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Urology Institute Research

Springfield, Oregon, 97477, United States

Location

Grand Strand Urology

Myrtle Beach, South Carolina, 29572, United States

Location

Corpus Christi Urology Group, LLP

Corpus Christi, Texas, 78404, United States

Location

Urology of Virginia

Newport News, Virginia, 23606, United States

Location

Andreou Research

Surrey, British Columbia, V3V 1N1, Canada

Location

Can-Med Clinical Research Inc.

Victoria, British Columbia, V8T 5G9, Canada

Location

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

Barrie, Ontario, L4M 7G1, Canada

Location

Urology Resource Centre

Burlington, Ontario, L7S 1V2, Canada

Location

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

Hamilton, Ontario, L8N 4A6, Canada

Location

Centre for Applied Urological Research

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

The Fe/Male Health Centre

Oakville, Ontario, L6H 3P1, Canada

Location

Todd Webster, M.D.

Owen Sound, Ontario, N4K 2J1, Canada

Location

The Scarborough Hospital

Scarborough Village, Ontario, M1P 2T7, Canada

Location

University of Toronto, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22998907DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

VB4-845

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Rachelle Dillon, Ph.D.
Organization
Sesen Bio
rachelle.dillon@sesenbio.com
204-452-7126

Study Officials

  • Wendy Chapman

    Sesen Bio, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 19, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 12, 2020

Results First Posted

May 12, 2020

Record last verified: 2020-04

Locations

US(8)CA(13)