Clinical trial NCT02311101: Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer
Official title: Sequential Intravesical Mitomycin Plus Bacillus Calmette-Guérin for Non-Muscle Invasive Urothelial Bladder Carcinoma: Translational and Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urinary Bladder Neoplasm
Keywords: bladder cancer
mitomycin
BCG
intravesical
non-muscle invasive
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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)

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: UT Health Science Center San Antonio
name: Robert S. Svatek, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.