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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Kansas Medical Center
Study ID
NCT06493370
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravenous ascorbic acid/vitamin C — DRUG
    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

Study Details

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 Dates

Start date
Jan 16, 2025
Status verified
Jul 2024
Primary completion
Dec 1, 2028
Completion
Dec 1, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous ascorbic acid/vitamin C
    2 Cycles Carboplatin Day 1 and Gemcitabine Days 1 and 8 (NAC) \+ Intravenous Vitamin C Days 1-28

Primary Outcome Measure

Post treatment pathological staging [ Time Frame: Approximately 10 to 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Holden Comprehensive Cancer Center - The University of IowaIowa CityIowa52242
Michael O'Donnell, MD
Michael O'Donnell, MD (PRINCIPAL_INVESTIGATOR)
The University of Kansas Cancer CenterKansas CityKansas66160
KUCC Navigation
[email protected]
913-588-3671
John Taylor III, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Holden Comprehensive Cancer Center - The University of Iowa· Iowa City, IAThe University of Kansas Cancer Center· Kansas City, KS

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