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Anti-metabolites
Vitamin C + Chemotherapy for Bladder Cancer
Phase 2
Waitlist Available
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status (PS) 0 - 2
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
Must not have
Is pregnant or breastfeeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to enroll patients with bladder cancer who cannot receive cisplatin or choose not to have cisplatin-based treatment. The study will look at how adding IVC to gemcitabine
Who is the study for?
This trial is for patients with muscle invasive bladder cancer who can't have cisplatin or choose not to. It's a phase II study, meaning it's checking the effectiveness and safety of adding high-dose vitamin C (IVC) to standard chemo drugs gemcitabine and carboplatin.
What is being tested?
The trial tests whether intravenous ascorbic acid (high-dose vitamin C) combined with gemcitabine/carboplatin chemotherapy can be an effective treatment that also improves quality of life for those with muscle invasive bladder cancer who aren't using cisplatin.
What are the potential side effects?
Potential side effects may include reactions at the injection site, fatigue from chemotherapy, kidney stones due to high levels of vitamin C, nausea, low blood counts increasing infection risk, and possible interference with glucose tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
I cannot or chose not to take Cisplatin for my bladder cancer due to specific health reasons.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Select...
I am not using, nor plan to use other cancer treatments during this study.
Select...
My cancer is either adenocarcinoma, squamous cell, or small cell type.
Select...
I have a history of G6PD deficiency.
Select...
I do not have any serious ongoing illnesses that are not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post treatment pathological staging
Secondary study objectives
To assess Quality of life (QOL)
To measure Disease Free Survival (DFS)
To measure Disease Specific Survival (DSS)
Other study objectives
Cellular outcome markers, IVC uptake, IVC specific mechanism markers, Cell death, Cell proliferation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intravenous ascorbic acid/vitamin CExperimental Treatment1 Intervention
2 Cycles Carboplatin Day 1 and Gemcitabine Days 1 and 8 (NAC)
+ Intravenous Vitamin C Days 1-28
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
512 Previous Clinical Trials
176,685 Total Patients Enrolled