Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase II study. This means that BCG therapy has already been found to be safe in humans. The investigators just want to see if using more treatments works better.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

NCT02138734

Non-muscle Invasive Bladder Cancer

RECRUITING PHASE1/PHASE2

PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer

NCT02326168

Bladder Cancer

COMPLETED EARLY_PHASE1

BCG for Therapeutic Use Phase Ⅲ Clinical Trial

NCT06747455

BCG

RECRUITING PHASE3

BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

NCT05943106

Non-Muscle- Invasive Bladder Cancer

ACTIVE_NOT_RECRUITING PHASE3

Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]

NCT03504163

Bladder Cancer

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer High Risk Superficial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bacillus Calmette-Guérin (BCG)

Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses.

Group Type EXPERIMENTAL

Bacillus Calmette-Guérin (BCG)

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bacillus Calmette-Guérin (BCG)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumors.
* 18 years and older
* All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation.
* Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment. Should the imaging or biopsy be performed outside this window it will be up to the physicians discretion to re-scan/biopsy.
* Patients who have received a single dose of mitomycin C following staging TUR.

Exclusion Criteria

* Currently being treated or scheduled to have radiation treatment for bladder cancer during the study.
* Treatment with intravesical BCG or chemotherapy for a patient's current \<T2 tumor during the 12 months prior to the current diagnosis.
* Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
* Currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer.
* Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the bladder.
* Currently being treated for metastatic transitional cell carcinoma.
* Scheduled to have surgery for bladder cancer during the study.
* Presence of clinically significant infections or congenital or acquired immunodeficiency.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No