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

NCT ID: NCT00462488

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-10-31

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).

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.

Conditions

Urinary Bladder Cancer; Bladder Cancer; Bladder Neoplasms; Bladder Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Schedule A -

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]).

Group Type: ACTIVE_COMPARATOR

Vicinium

Intervention Type: DRUG

Intravesical administration of Vicinium

Treatment Schedule B

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).

Group Type: ACTIVE_COMPARATOR

Vicinium

Intervention Type: DRUG

Intravesical administration of Vicinium

Interventions

Vicinium

Intravesical administration of Vicinium

Intervention Type: DRUG

Other Intervention Names

VB4-845

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sesen Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Chapman

Role: STUDY_DIRECTOR

Sesen Bio, Inc.

Locations

Southeastern Research Group, Inc.

Tallahassee, Florida, United States

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Lawrenceville Urology

Lawrenceville, New Jersey, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Urology Institute Research

Springfield, Oregon, United States

Grand Strand Urology

Myrtle Beach, South Carolina, United States

Corpus Christi Urology Group, LLP

Corpus Christi, Texas, United States

Urology of Virginia

Newport News, Virginia, United States

Andreou Research

Surrey, British Columbia, Canada

Can-Med Clinical Research Inc.

Victoria, British Columbia, Canada

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

Barrie, Ontario, Canada

Urology Resource Centre

Burlington, Ontario, Canada

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

Hamilton, Ontario, Canada

Centre for Applied Urological Research

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Fe/Male Health Centre

Oakville, Ontario, Canada

Todd Webster, M.D.

Owen Sound, Ontario, Canada

The Scarborough Hospital

Scarborough Village, Ontario, Canada

University of Toronto, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 22998907 (View on PubMed)

Other Identifiers

VB4-845-02-IIA

Identifier Type: -

Identifier Source: org_study_id