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

NCT04046094 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 2 other identifiers: IIT-2019-IVC_CarboGemUL1TR002366
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bladder Cancer

Keywords

Intravenous (IV) Ascorbic Acid (Vitamin C)

Outcome Measures

Primary Outcomes (1)

• Post Treatment Pathological Staging

  Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.

  6 weeks after first IVC infusion at radical cystectomy

Secondary Outcomes (2)

• Overall Change in Patient-reported Quality of Life Outcomes

  Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)

• Disease Free Survival Rate (DFS) Among Participants

  5 years

Study Arms (1)

IV Ascorbic Acid

EXPERIMENTAL

IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks

Drug: Ascorbic Acid

Interventions

Ascorbic Acid DRUG

Ascorbic Acid Intravenous

Also known as: Vitamin C

IV Ascorbic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (3)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, 66205, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Faith Rahman
• Organization: University of Kansas Medical Center

frahman2@kumc.edu

913-588-2502

Study Officials

• John Taylor, MD MS

  The University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Basic Urologic Research, Co-Leader of D3ET

Model Details: To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: October 17, 2019
• Primary Completion: September 12, 2022
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2025
• Results First Posted: March 4, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)