Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Bladder Cancer

In brief

Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients. However, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. Although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by NAC. Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. This trial will add IVC to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.

Key facts

Study ID

NCT04046094

Run by

University of Kansas Medical Center

People needed

12

Starts

2019-10-17

Expected to finish

2026-08-01

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
• Cisplatin-ineligible, muscle invasive bladder cancer
• Adequate organ and marrow functions
• Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control

You may not qualify if…

• Patient simultaneously enrolled in any therapeutic clinical trial
• Current or anticipated use of other investigational agents while participating in this study
• Psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
• Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
• Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder
• Uncontrolled intercurrent illness
• Current consumption of tobacco products
• History of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Where it is running

• The University of Kansas Cancer Center (KUCC) — Fairway, Kansas, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• The University of Kansas Cancer Center, Westwood Campus — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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