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IV Vitamin C + Chemotherapy for Bladder Cancer

Phase 1 & 2
Waitlist Available
Led By John Taylor, MD MS
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
Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
Cisplatin-ineligible, muscle invasive bladder cancer
Must not have
Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
History of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding intravenous ascorbate (vitamin C) to gemcitabine/carboplatin chemotherapy will increase therapeutic efficacy in patients with bladder cancer who are ineligible for cisplatin-based chemotherapy.

Who is the study for?
This trial is for adults with muscle invasive bladder cancer who can't have cisplatin-based chemotherapy. They must be in fair to good health, not pregnant or breastfeeding, and willing to use birth control. Smokers and those with certain medical conditions or treatments are excluded.
What is being tested?
The study tests if adding high-dose vitamin C (IVC) to the chemo drugs carboplatin and gemcitabine helps treat bladder cancer better than chemo alone. It's for patients who can't tolerate the usual cisplatin drug due to other health issues.
What are the potential side effects?
High-dose IV vitamin C may cause side effects like headache, fatigue, nausea, and possible complications at the injection site. When combined with chemotherapy drugs, there might also be increased risk of blood disorders and organ stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I cannot receive cisplatin and have muscle invasive bladder cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have a history of G6PD deficiency.
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I do not have any uncontrolled illnesses.
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I have had chemotherapy or radiation therapy for bladder issues before.
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My bladder cancer is of a specific type (adenocarcinoma, squamous cell, or small cell).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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
Disease Free Survival Rate (DFS) Among Participants
Overall Change in Patient-reported Quality of Life Outcomes

Side effects data

From 2019 Phase 4 trial • 66 Patients • NCT02209636
38%
Non-serious adverse events
3%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lanthanum Carbonate
Placebo
Placebo- Phosphorus Balance Sub-study
Lanthanum Carbonate- Phosphorus Balance Sub-study

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: IV Ascorbic AcidExperimental Treatment1 Intervention
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic Acid
2017
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,883 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
365 Previous Clinical Trials
412,602 Total Patients Enrolled
John Taylor, MD MSPrincipal Investigator - The University of Kansas
Centerpoint Medical Center, Discover Vision Center
University Of Mo-Kansas City School Of Medicine (Medical School)
University Mo Kc Affil Hosps (Residency)

Media Library

Ascorbic Acid Clinical Trial Eligibility Overview. Trial Name: NCT04046094 — Phase 1 & 2
Bladder Cancer Research Study Groups: IV Ascorbic Acid
Bladder Cancer Clinical Trial 2023: Ascorbic Acid Highlights & Side Effects. Trial Name: NCT04046094 — Phase 1 & 2
Ascorbic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046094 — Phase 1 & 2
~2 spots leftby Nov 2025
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