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RECRUITING
NCT06493370
PHASE2

Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-01-16

Completion Date

2030-12-01

Last Updated

2025-02-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Intravenous ascorbic acid/vitamin C

A dose escalation regimen will be initiated for each participant at a single dose of 25 g, titrated to up target peak plasma concentration. Once established, IVC will be administered intravenously 2 times per week for the remaining cycles

Locations (2)

Holden Comprehensive Cancer Center - The University of Iowa

Iowa City, Iowa, United States

The University of Kansas Cancer Center

Kansas City, Kansas, United States