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

Last updated: March 17, 2025
Sponsor: University of Kansas Medical Center
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

Ascorbic Acid

Clinical Study ID

NCT04046094
IIT-2019-IVC_CarboGem
UL1TR002366
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 potentialmust agree to use protocol specified forms of birth control

Exclusion

Exclusion Criteria:

  • Patient simultaneously enrolled in any therapeutic clinical trial

  • Current or anticipated use of other investigational agents while participating inthis study

  • Psychiatric illness/social situations that would limit compliance with studyrequirements

  • Pregnant or breast feeding. There is a potential for congenital abnormalities andfor this regimen to harm breast feeding infants

  • Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cellcarcinoma in the TURBT sample

  • Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or priorradiation therapy to the urinary bladder

  • Uncontrolled intercurrent illness

  • Current consumption of tobacco products

  • History of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Ascorbic Acid
Phase: 1/2
Study Start date:
October 17, 2019
Estimated Completion Date:
August 31, 2026

Study Description

see protocol

Connect with a study center

  • The University of Kansas Cancer Center (KUCC)

    Fairway, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

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