Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer

December 1, 2015 updated by: Robert Svatek, The University of Texas Health Science Center at San Antonio

Sequential Intravesical Mitomycin Plus Bacillus Calmette-Guérin for Non-Muscle Invasive Urothelial Bladder Carcinoma: Translational and Phase I Clinical Trial

The study aims to establish the safety and toxicity of a combined intravesical mitomycin C with BCG for patients with bladder cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urine Sample Collection and Handling: Voided urine will be collected pre and post BCG procedure. Urinalysis will be performed if participant presents with urinary symptoms. Analysis of urinary cytokines as predictors of response to therapy will be conducted by ELISA kits.

Tissue Sample Collection and Handling: Tissue biopsy specimens will be collected pre BCG procedure. Analysis of gene expression will be conducted.

TEST PROCEDURES Subjects will be given one of three concentrations of Mitomycin C (MMC) (10 mg in 20 mL, 20 mg in 20 ml or 40 mg in 20 ml) for 30 minutes followed by a 10 minute washout period. Followed by three concentrations of BCG including ¼ strength, ½ strength, and full strength for 2 hours. Dose escalation will take place among subsequent patients and not within each patient.

Approximately 30 subjects will be enrolled to reach the target completion enrollment of 10 subjects.

Long-term Follow-up A Chart review will be conducted every three months for 2 years after initial 6 month study data collection. Patient charts will be reviewed to assess disease progression and any data supporting findings. Long-term follow-up is necessary to determine recurrence rates and long-term safety and efficacy of Mitomycin/BCG treatment therapy as well as BCG therapy in the control group.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Newly diagnosed or recurrent multi-focal Ta, large Ta, high-grade Ta, CIS, or T1 bladder cancer
  2. In urologist's opinion a good candidate for BCG induction therapy
  3. Be able to give informed consent
  4. Be age 18 or older.

Exclusion Criteria:

  1. Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3)
  2. Immunosuppressed state (e.g. HIV, use of chronic steroids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Therapy Group MMC 10/BCG Half

Intravesical Mitomycin C and intravesical BCG

First intravesical mitomycin C (10 mg) is instilled for 30 minutes. Then the mitomycin is removed and the bladder is gently hand-irrigated with sterile water for 15 minutes in order to facilitate removal of mitomycin C. Then, intravesical BCG (half dose) is instilled for 2 hours under usual conditions. Full dose BCG corresponds to 1 to 8x10^8 colony-forming units of BCG. This study targets patients with BCG-naive or BCG-refractory high-risk non-muscle invasive bladder cancer. The first 3 participants received 10mg of MMC and half dose of BCG. The dose was assigned in order of enrollment.
Drug: Mitomycin C
Given intravesically
Other Names:
  • BCG
EXPERIMENTAL: Therapy Group MMC 10/BCG Full
First intravesical mitomycin C (10 mg) is instilled for 30 minutes. Then the mitomycin is removed and the bladder is gently hand-irrigated with sterile water for 15 minutes in order to facilitate removal of mitomycin C. Then, intravesical BCG (full dose) is instilled for 2 hours under usual conditions. Full dose BCG corresponds to 1 to 8x10^8 colony-forming units of BCG. This study targets patients with BCG-naive or BCG-refractory high-risk non-muscle invasive bladder cancer. The following 3 participants received 10mg of MMC and full dose BCG. Dose was assigned in order of enrollment.
Drug: Mitomycin C
Given intravesically
Other Names:
  • BCG
EXPERIMENTAL: Therapy Group MMC 20/BCG Full
First intravesical mitomycin C (20 mg) is instilled for 30 minutes. Then the mitomycin is removed and the bladder is gently hand-irrigated with sterile water for 15 minutes in order to facilitate removal of mitomycin C. Then, intravesical BCG (full dose) is instilled for 2 hours under usual conditions. Full dose BCG corresponds to 1 to 8x10^8 colony-forming units of BCG. This study targets patients with BCG-naive or BCG-refractory high-risk non-muscle invasive bladder cancer. The next 3 participants enrolled received 20mg of MMC and full dose BCG. Dose was assigned in order of enrollment.
Drug: Mitomycin C
Given intravesically
Other Names:
  • BCG
EXPERIMENTAL: Therapy Group MMC 40/BCG Full
First intravesical mitomycin C (40 mg) is instilled for 30 minutes. Then the mitomycin is removed and the bladder is gently hand-irrigated with sterile water for 15 minutes in order to facilitate removal of mitomycin C. Then, intravesical BCG (full dose) is instilled for 2 hours under usual conditions. Full dose BCG corresponds to 1 to 8x10^8 colony-forming units of BCG. This study targets patients with BCG-naive or BCG-refractory high-risk non-muscle invasive bladder cancer. The last 3 participants received 40mg of MMC and full dose BCG. Dose was assigned in order of enrollment.
Drug: Mitomycin C
Given intravesically
Other Names:
  • BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: Up to 3 months
The primary objective of this study is to determine the MTD for sequential MMC with BCG and thereby establish a recommended phase 2 dose of the combined therapy.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Robert S. Svatek, MD, MSCI, UT Health Science Center San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 14, 2013

First Submitted That Met QC Criteria

December 4, 2014

First Posted (ESTIMATE)

December 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20120003H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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