Using vitamin C with chemotherapy for bladder cancer treatment
Official title: Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
Run by University of Kansas Medical Center · NCT06493370 · Data updated 2026-11-12
This study is testing if adding vitamin C to standard chemotherapy can help people with muscle invasive bladder cancer feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Status | Recruiting |
| Started | January 16, 2025 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2030 |
| Registry record updated | February 20, 2025 |
| Trial ID | NCT06493370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with muscle invasive bladder cancer who are either ineligible for or have declined cisplatin-based neoadjuvant chemotherapy.
✕Probably not a fit
Patients with muscle invasive bladder cancer who are eligible for cisplatin-based therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial investigates the effects of adding intravenous ascorbate (vitamin C) to gemcitabine and carboplatin chemotherapy in patients with muscle invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based neoadjuvant chemotherapy. The study employs a Simon two-stage design to assess the rates of pathological downstaging and quality of life improvements in these patients. Participants will receive two cycles of the chemotherapy regimen along with vitamin C before proceeding to cystectomy within 12 weeks of diagnosis.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and tolerable treatment option for patients with muscle invasive bladder cancer who cannot receive standard cisplatin therapy.
How similar studies have gone: While the combination of vitamin C with chemotherapy is a novel approach, previous studies have shown promising results with vitamin C in cancer treatment, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent * Consent to participate in biorepository protocol number GUB-BCR-001, KU IRB Approved HSC # STUDY00141546 * Males and females age ≥ 18 years * ECOG Performance Status (PS) 0 - 2 * Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment. * Diagnosis/disease status Cisplatin-ineligible or declined muscle invasive bladder cancer. Cisplatin ineligibility will be defined based on Galsky criteria: CTCAE ver. 5.0 Grade 2 or greater peripheral neuropathy; CTCAE ver. 5.0 Grade 2 or greater hearing loss; Creatinine clearance estimated or calculated \< 60 ml/min; NYHA class II or greater congestive heart failure * Adequate organ function, defined as follows: Absolute Neutrophil Count \>1.5K/UL. (NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 based on discretion of the treating physician.); Platelets \>100K/UL; Hemoglobin ≥ 9 g/dL; Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation; Total bilirubin ≤ 2.0 x ULN; Aspartate aminotransferase (AST \[SGOT\]) and alanine aminotransferase (ALT \[SGPT\]) ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN; Normal Glucose-6-phosphate dehydrogenase (G6PD) status * Women of child-bearing potential (WOCBP) and men with partners of child-bearing potential must agree not to donate sperm (men), to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for WOMEN: 6 months after EOT, MEN: 3 months after EOT following completion of therapy. Exclusion Criteria: * Simultaneously enrolled in any therapeutic clinical trial * Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study * Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements * Is pregnant or breastfeeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants * Women of childbearing age expecting to conceive children while receiving study treatment and for 6 months after the last dose of study treatment. Men expecting to conceive children while receiving study treatment and for 3 months after the last dose of study treatment * Has a severe known allergic reaction to any excipient contained in the study drug formulation * Active Grade 3 or 4 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0109) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment. * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, as determined per treating physician. * Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample * Current consumption of tobacco products, patients may be asked to quit for 2 weeks prior to enrollment * If tobacco use is suspected at any point during the trial, cotinine level will be obtained * History of G6PD deficiency * History of oxalate renal calculi - per discretion of treating physician
Where it's running
-
The University of Kansas Cancer Center
Kansas City, Kansas, United States Recruiting -
Holden Comprehensive Cancer Center - The University of Iowa
Iowa City, Iowa, United States Not yet recruiting
Study contacts
- Study coordinator: KUCC Navigation
- Email: kucc_navigation@kumc.edu
- Phone: 913-588-3671
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.