Urothelial CarcinomaPhase 2NCT03658304

Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma

A Phase 2 study testing Mitomycin c in people with Urothelial Carcinoma, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Urothelial Carcinoma
What is being tested?: Mitomycin c
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2018to 17 Oct 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32608

Other trials in United States

About this study

Official title: A Single Arm Phase II Trial of the Intraoperative Intravesical Instillation of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract

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
Being tested: Mitomycin c
Medical subject headings: Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mitomycin cDrug
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.

Study groups in NCT03658304
Study group	Role	What they receive
Mitomycin C	Experimental	Not described Receives: Drug: Mitomycin c

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 year

Secondary outcomes (2)

Time to Bladder Tumor Recurrence
Determine the median time to bladder tumor recurrence. A subject is considered to have had a bladder tumor recurrence when they have been confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy.
Measured: 3 years
Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively
Determine the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy 3 years post-operatively.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201817 Oct 2023

First posted5 Sep 2018
Study start5 Dec 2018
Primary completion10 Nov 2021
Study completion17 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03658304
Sponsor's protocol ID: UF-GU-001
Other IDs: OCR18677, IRB201802090
Status last verified: Nov 2024
First submitted: 31 Aug 2018
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

All Urothelial Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm Phase II Trial of the Intraoperative Intravesical Instillation of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
ClinicalTrials.gov ID: NCT03658304
Acronym / sponsor ID: UF-GU-001
Conditions: Urothelial Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 5 Dec 2018 (actual)
Primary completion: 10 Nov 2021 (actual)
Study completion: 17 Oct 2023 (actual)
First posted: 5 Sep 2018 (actual)
Results: Posted 2 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mitomycin C	Experimental	Drug: Mitomycin c

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mitomycin cAll 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.	Drug	Mitomycin C

Primary outcome

Bladder Tumor Recurrence Rate
Time frame: 1 year
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

2 secondary outcomes

Time to Bladder Tumor Recurrence
Time frame: 3 years
Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively
Time frame: 3 years

Results and safety

Results posted to the registry on 2 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mitomycin C	29	29

Primary outcome: Bladder Tumor Recurrence Rate

Time frame: 1 year. Number. Unit: percentage of subjects

Measure	Mitomycin C n = 29
Value	41.37

Population analysed: all 29 subjects enrolled have reached the 1 year post-surgery timepoint.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mitomycin C	1 of 29 (3.4%)	27 of 29 (93.1%)	4 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Urothelial Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Crispen, MD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitomycin c in people with Urothelial Carcinoma, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bladder Tumor Recurrence Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.