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Intravenous Ascorbate Plus Chemotherapy for Bladder Cancer

This study is testing if adding intravenous ascorbic acid (vitamin C) to gemcitabine and carboplatin chemotherapy can help patients with muscle invasive bladder cancer (MIBC). This trial is for patients who cannot receive cisplatin chemotherapy or choose not to. Researchers want to see if this combination can shrink tumors before surgery (pathological downstaging) and improve your quality of life. You would receive two cycles of gemcitabine/carboplatin along with intravenous ascorbic acid, then proceed to surgery. The study aims to enroll 48 participants aged 18 or older with a good performance status (ECOG PS 0-2). The main goal is to measure how much the tumors shrink after treatment, which is checked around 10 to 12 weeks after starting the study.

Study design
This is a Phase 2, single-arm study, meaning all participants receive the same treatment. It plans to enroll 48 participants.
What's involved
You will receive intravenous ascorbic acid two times per week for the duration of the chemotherapy cycles. You will also have a cystectomy (bladder removal surgery) after two cycles of treatment.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured approximately 10 to 12 weeks after treatment, which is when post-treatment pathological staging occurs.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06493370

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Kansas Medical Center
~48 participants
Updated 2025-02-20 on ClinicalTrials.gov
What's tested:Intravenous ascorbic acid/vitamin C

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post treatment pathological staging
Measured over Approximately 10 to 12 weeks

Conditions

Bladder Cancer

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Bladder Carcinoma

NCT06493370

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Kansas Cancer Center

    Kansas City, Kansasstudy coordinator listed

    Recruiting

  • Holden Comprehensive Cancer Center - The University of Iowa

    Iowa City, Iowano site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

KUCC Navigation
[email protected]
913-588-3671
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Post treatment pathological stagingApproximately 10 to 12 weeks

    To assess pathologic downstaging rate in MIBC cisplatin-ineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen. Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines.