Intravesical BCG Administration to Patients With Invasive Bladder Cancer

NCT ID: NCT02365207

Last Updated: 2019-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-04-25

Brief Summary

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Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.

Detailed Description

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Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.

After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BCG treatment of invasive bladder cancer

Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

Group Type EXPERIMENTAL

BCG strain of Mycobacterium bovis

Intervention Type DRUG

Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

Interventions

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BCG strain of Mycobacterium bovis

Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

Intervention Type DRUG

Other Intervention Names

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BCG

Eligibility Criteria

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Inclusion Criteria

1. Have suspected or known invasive (≥T1) bladder cancer
2. Be able to give informed consent
3. Be age 18 or older
4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)

Exclusion Criteria

1. Have non-invasive (\<T1) bladder cancer
2. Unable to give informed consent
3. \< 18 or older
4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Svatek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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MARC - The University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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14-002

Identifier Type: -

Identifier Source: org_study_id

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