Compassionate Use of MitoGel in Upper Tract Urothelial Carcinoma

NCT02701023 | Unknown

• 1 other identifier: 16-000080
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility, safety, and efficacy of MitoGel in the treatment of UTUC in a human subject with low-grade UTUC which is endoscopically unresectable or rapidly recurring, and in whom nephrectomy would likely result in the need for permanent hemodialysis. The study drug would be obtained under the single patient access program approved by the FDA. The patient would then undergo instillation of MitoGel into the affected kidney. The catheter would be left indwelling in the ureter and would be externalized. The ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments, which would occur twice weekly for 3 weeks or once weekly for 6 weeks. Following the final instillation, the catheters would be removed. The patient would then undergo ureteroscopic evaluation at 3 months following the final instillation of MitoGel. The total duration of study would be 3 months. The total number of study patients is 1.

Conditions

Urothelial Carcinoma Ureteral Location

Interventions

MitoGel DRUG

The patient would then undergo instillation of MitoGel into the affected kidney. The catheter would be left indwelling in the ureter and would be externalized through a urethral catheter. The ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments, which would occur twice weekly for 3 weeks. Following the final instillation, the catheters would be removed. The patient would then undergo ureteroscopic evaluation at 3 months following the final instillation of MitoGel. The total duration of study would be 3 months.

Eligibility Criteria

• Age: 76 Years - 77 Years
• Sex: male
• Age Groups: Older Adult (65+)

You may qualify if:

• Therapy to be utilized as part of the FDA Compassionate use IND
• Histologically confirmed low grade upper tract urothelial carcinoma which is high-volume and difficult to control using standard ablative therapies
• Anatomically solitary kidney or renal insufficiency significant enough such that nephroureterectomy would result in dialysis dependence
• Willing to consent and participate in a single-patient expanded access use under an FDA IND agreement
• Willing to maintain an indwelling foley catheter for a period of 3 weeks

You may not qualify if:

• Hypersensitivity to mitomycin C or any of the other drug components
• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
• Has an active urinary tract infection
• Is unable to tolerate the treatments
• Demonstrates progressively worsening renal dysfunction
• Has a known additional malignancy that is progressing or requires active treatment
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• UroGen Pharma Ltd.: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)