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

NCT02311101 | Completed Phase 1 DMC

• 1 other identifier: HSC20120003H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Bladder Neoplasm

Keywords

bladder cancer; mitomycin; BCG; intravesical; non-muscle invasive

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  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

Study Arms (4)

Therapy Group MMC 10/BCG Half

EXPERIMENTAL

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

Therapy Group MMC 10/BCG Full

EXPERIMENTAL

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

Therapy Group MMC 20/BCG Full

EXPERIMENTAL

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

Therapy Group MMC 40/BCG Full

EXPERIMENTAL

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

Interventions

Mitomycin C DRUG

Given intravesically

Also known as: BCG

Therapy Group MMC 10/BCG Full; Therapy Group MMC 10/BCG Half; Therapy Group MMC 20/BCG Full; Therapy Group MMC 40/BCG Full

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Hilton WM, Ercole B, Parekh DJ, Sonpavde G, Ghosh R, Svatek RS. Efficacy of combined intravesical immunotherapy and chemotherapy for non-muscle invasive bladder cancer. Expert Rev Anticancer Ther. 2011 Jun;11(6):949-57. doi: 10.1586/era.11.69.

  PMID: 21707292 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert S. Svatek, MD, MSCI

  UT Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Urologic Oncology

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: December 8, 2014
• Study Start: March 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)