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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: Ascorbic Acid; Cisplatin; Vitamins

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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