Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma

NCT03658304 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: UF-GU-001OCR18677IRB201802090
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Results of previous studies suggest that the timing of intravesical mitomycin C administration may impact bladder tumor recurrence rate following radical nephroureterectomy. This is the first study of its kind to attempt to identify the importance of timing of mitomycin C administration relative to bladder tumor recurrence rate following radical nephroureterectomy.This study will investigate the one year bladder tumor recurrence rate in patients with urothelial carcinoma of the upper urinary tract following intraoperative administration of mitomycin C during a nephroureterectomy, as well as the time to bladder tumor recurrence in this patient population.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Bladder Tumor Recurrence Rate

  The bladder tumor recurrence rate will be measured by the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy

  1 year

Secondary Outcomes (2)

• Time to Bladder Tumor Recurrence

  3 years

• Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively

  3 years

Study Arms (1)

Mitomycin C

EXPERIMENTAL

Drug: Mitomycin c

Interventions

Mitomycin c DRUG

All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.

Mitomycin C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both males and females ≥ eighteen years of age
• Clinical diagnosis of urothelial carcinoma of the renal pelvis and/or ureter. Clinical diagnosis of urothelial carcinoma may be based upon radiographic, pathologic or cytological findings alone or in combination with one another. No other histology is allowed.
• The TNM stage of the subject's disease (using the American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition) must be Tis, Ta, T1, T2, or T3, N0, M0. Subjects may have either a high-grade or low-grade tumor.
• ECOG performance status of 0-2
• Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy prior to and for at least 3 months after mitomycin C instillation to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
• Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) should avoid conceiving children prior to and for 3 months following mitomycin C instillation
• Subjects must have hemoglobin ≥ 9 g/dL and a platelet count ≥ 100,000/μL.

You may not qualify if:

• Active urothelial carcinoma of the bladder within 12 months prior to enrollment
• History of adverse reaction to mitomycin C
• Evidence of regional or metastatic disease.
• History of radical cystectomy
• Planned radical cystectomy at the time of nephroureterectomy
• Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy prior to and for at least 3 months after mitomycin C instillation.
• Females who are pregnant or breastfeeding.
• History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• Subjects demonstrating an inability to comply with the study and/or follow-up procedures

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Allison Allegra
• Organization: University of Florida

allisonallegra3@ufl.edu

352-294-5691

Study Officials

• Paul Crispen, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: December 5, 2018
• Primary Completion: November 10, 2021
• Study Completion: October 17, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 2, 2022

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)