Intravesical Gemcitabine in Patients With NMIBC

Status Recruiting

Clinical Trial Summary

Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer is a well-established treatment for preventing or delaying tumor recurrence after bladder tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line, nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. In addition, nationwide shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At Banner University Medical-Tucson, the use of intravesical Gemcitabine is considered as standard treatment for patients with bladder cancer who are unable to get BCG or have failed prior BCG treatment. The role of Gemcitabine as treatment for NBMIC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine intravesical chemotherapy for non-muscle invasive bladder cancer in a prospective cohort of patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05644041
Study type	Interventional
Source	University of Arizona
Contact	Juan Chipollini, MD
Phone	(520) 626-6895
Email	jchipollini@urology.arizona.edu
Status	Recruiting
Phase	Phase 2
Start date	March 1, 2023
Completion date	January 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT00872495` - Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
Withdrawn	`NCT05335707` - Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy
Completed	`NCT03998579` - Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer	N/A
Not yet recruiting	`NCT04525781` - Clinicoepidimiological Study and Clinical Outcome in Patients With Urinary Bladder Cancer
Completed	`NCT02897765` - A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer	Phase 1
Recruiting	`NCT05822934` - Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer	Phase 3
Completed	`NCT06156787` - Patterns of Urinary Bladder Cancer in Darfur, Suda
Completed	`NCT02722538` - Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer	Phase 1
Completed	`NCT02437539` - Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography	Phase 1
Completed	`NCT02139371` - Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography	Phase 0
Completed	`NCT03433924` - An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.
Active, not recruiting	`NCT03132922` - MAGE-A4ᶜ¹º³²T for Multi-Tumor	Phase 1
Completed	`NCT05946369` - Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
Completed	`NCT00462488` - Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ	Phase 2
Recruiting	`NCT05621837` - Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
Completed	`NCT04635566` - Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute	N/A
Recruiting	`NCT04861584` - Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects	Phase 2
Completed	`NCT01836978` - Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy	N/A
Terminated	`NCT01374789` - PURO Panitumumab in Combination With Gemcitabine/Cisplatin in Advanced Urothelial Cancer	Phase 2
Recruiting	`NCT03844256` - A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study	Phase 1/Phase 2