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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311101
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Robert Svatek, The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasm Drug: Mitomycin C Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Intravesical Mitomycin Plus Bacillus Calmette-Guérin for Non-Muscle Invasive Urothelial Bladder Carcinoma: Translational and Phase I Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: 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 Name: 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 Name: 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 Name: BCG




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311101


Locations
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United States, Texas
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Robert S. Svatek, MD, MSCI UT Health Science Center San Antonio
Publications:
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Responsible Party: Robert Svatek, Assistant Professor, Division of Urologic Oncology, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02311101    
Other Study ID Numbers: HSC20120003H
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Robert Svatek, The University of Texas Health Science Center at San Antonio:
bladder cancer
mitomycin
BCG
intravesical
non-muscle invasive
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors