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Alkylating agents

Mitomycin c for Bladder Cancer

Phase 2
Waitlist Available
Led By Paul Crispen, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will study if earlier administration of mitomycin C during nephroureterectomy surgery will improve the one year bladder tumor recurrence rate in patients with urothelial carcinoma of the upper urinary tract.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Urinary Bladder
Urinary Bladder

Side effects data

From 2023 Phase 2 trial • 29 Patients • NCT03658304
21%
Creatinine increased
17%
Vomiting
14%
Anemia
14%
Nausea
14%
Constipation
7%
Pain
7%
Hiccups
7%
Dizziness
7%
Pain in extremity
7%
Delirium
7%
Urinary tract infection
7%
Back pain
7%
Hyperkalemia
7%
Fatigue
7%
Diarrhea
7%
Urinary retention
7%
Dyspnea
5%
Bruising
5%
Dental caries
5%
Blood and lymphatic system disorders - Other, specify
5%
Gastrointestinal disorders - other, specify
5%
Gastrointestinal disorders, other
5%
Dysesthesia
5%
Musculoskeletal and connective tissue disorders, other
5%
Metabolism and nutrition disorders, other
5%
Malaise
5%
Sleep apnea
5%
Urinary Tract Infection
5%
Hypocalcemia
5%
Dysgeusia
3%
Melena
3%
Hyperhidrosis
3%
Hyperglycemia
3%
Hypomagnesemia
3%
GI upset
3%
Gastrointestinal pain
3%
Chest pain
3%
Bloating
3%
Hypercapnia
3%
White blood cell decreased
3%
Sinus tachycardia
3%
Phlebitis
3%
Cellulitis
3%
Hyponatremia
3%
Muscle weakness
3%
Fever
3%
Pruritis
3%
Wound complication
3%
Vertigo
3%
Hematuria
3%
Hypotension
3%
Hypophosphatemia
3%
Abdominal pain
3%
Abdominal distension
3%
Edema limbs
3%
Acute kidney injury
3%
Urinary frequency
3%
Urine output decreased
3%
Hypoxia
3%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mitomycin C

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mitomycin CExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitomycin c
2021
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,676 Total Patients Enrolled
Paul Crispen, MDPrincipal InvestigatorUniversity of Florida

Media Library

Mitomycin C (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03658304 — Phase 2
Bladder Cancer Research Study Groups: Mitomycin C
Bladder Cancer Clinical Trial 2023: Mitomycin C Highlights & Side Effects. Trial Name: NCT03658304 — Phase 2
Mitomycin C (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03658304 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant capacity for this research endeavor?

"This trial is presently closed to patient recruitment. It was initially posted on December 5th 2018 and the most recent edit took place October 31st 2022. If you are searching for a different study, there exist 2515 studies actively enrolling patients with carcinoma and 40 trials recruiting participants taking Mitomycin c medications."

Answered by AI

Is the trial accepting new applicants at this time?

"Clinicaltrials.gov reports that the given trial, first posted on December 5th 2018, is not presently accepting candidates. Nonetheless, there are currently 2555 other studies actively recruiting participants."

Answered by AI

Can you provide details about any prior experiments regarding Mitomycin c?

"As of today, there are 40 active studies involving Mitomycin c with 10 in their terminal stage. While a handful of these clinical trials take place in Bethesda, Maryland, the drug can be studied at 2029 locations globally."

Answered by AI

Might I be a suitable candidate for this research endeavor?

"This clinical trial is enrolling 29 individuals diagnosed with carcinoma, ranging between 18 to 99 years of age. All potential candidates must adhere to the following criteria: diagnosis of urothelial carcinoma through radiographic, pathologic or cytological findings; Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2; written consent and compliance with all study related procedures; for women of childbearing potential an adequate contraception method must be employed prior to and at least three months after mitomycin C instillation in order to avoid pregnancy risk factors; males are obliged to use contraceptive methods if female partners are under consideration for conception"

Answered by AI

What conditions can Mitomycin c be utilized to treat?

"Mitomycin c has been known to efficiently combat cervical cancers and can provide relief from other illnesses, such as glaucoma, mesotheliomas, and low-grade upper tract urothelial cancer (lg-utuc)."

Answered by AI

Is the age limit for participation in this experiment greater than 65 years old?

"This trial only accepts applicants between 18 and 99 years old. Separately, there are 77 trials for young adults under the age of 18 and 2533 studies open to those above 65."

Answered by AI

Has Mitomycin c been granted authorization by the FDA?

"Data from Phase 2 clinical trials suggests Mitomycin c may be relatively safe, so it was assigned a score of 2. Unfortunately, there is yet to be any data that supports its efficacy."

Answered by AI
~5 spots leftby Apr 2025