Using vitamin C with chemotherapy for bladder cancer treatment

Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer

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
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Kansas Medical Center (Academic / other)
• Locations: 2 sites (Iowa City, Iowa and 1 other locations)
• Trial ID: NCT06493370 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with muscle invasive bladder cancer who are eligible for cisplatin-based therapy may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Iowa City, Iowa and 1 other locations

• Holden Comprehensive Cancer Center - The University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
• The University of Kansas Cancer Center — Kansas City, Kansas, United States (Recruiting)

Study contacts

• Study coordinator: KUCC Navigation

Conditions Bladder Cancer