NCT00003779

Brief Summary

RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which type of BCG is more effective for bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of BCG in treating patients who have bladder cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

2.6 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2019

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancer

Outcome Measures

Primary Outcomes (1)

  • Assess role of prior exposition to mycobacteria

    6 weeks

Secondary Outcomes (1)

  • Define role of fever occurrence as potential indicator for BCG reactivity

    6 weeks

Study Arms (2)

BCG-Connaught

ACTIVE COMPARATOR
Biological: Connaught

BCG Onko-Tice

ACTIVE COMPARATOR
Biological: Tice

Interventions

ConnaughtBIOLOGICAL

Compare two strains of BCG

BCG-Connaught
TiceBIOLOGICAL

Compare two strains of BCG

BCG Onko-Tice

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed completely resected T1 or Ta papillary tumors of the urinary bladder TaG2 greater than 2 relapses in 2 years TaG3 unifocal or multifocal Unifocal primary T1G2-3 after a histological tumor-free second resection If multiple/multifocal, worst stage and grade AND/OR Histologically and cytologically confirmed primary or secondary carcinoma in situ of the urinary bladder No persistent T1 disease in second resection No contracted bladder (bladder capacity less than 80 mL) or bladder irritation within past 5 years No urothelial carcinoma of the upper urinary tract or the urethra PATIENT CHARACTERISTICS: Age: 18 to 90 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Liver function no greater than 1.5 times upper limit of normal (ULN) Renal: Renal function no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent malignancies except basocellular carcinoma No congenital or acquired immunosuppression (e.g., HIV, leukemia, lymphoma, transplant recipient) No uncontrollable or untreated urinary tract infection No chronic recurring bacterial cystitis PRIOR CONCURRENT THERAPY: Biologic therapy: No prior BCG therapy Chemotherapy: At least 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 5 years since prior radiotherapy to the bladder Surgery: See Disease Characteristics Other: No prior tuberculostatic therapy No concurrent local antiseptics or antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • Rentsch CA, Birkhauser FD, Biot C, Gsponer JR, Bisiaux A, Wetterauer C, Lagranderie M, Marchal G, Orgeur M, Bouchier C, Bachmann A, Ingersoll MA, Brosch R, Albert ML, Thalmann GN. Bacillus Calmette-Guerin strain differences have an impact on clinical outcome in bladder cancer immunotherapy. Eur Urol. 2014 Oct;66(4):677-88. doi: 10.1016/j.eururo.2014.02.061. Epub 2014 Mar 12.

    PMID: 24674149RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • George N. Thalmann, MD

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 15, 2004

Study Start

November 1, 1998

Primary Completion

June 1, 2001

Study Completion

June 1, 2010

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations

CH(1)