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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am able to get out of my bed or chair and move around.
Select...
I cannot receive cisplatin and have muscle invasive bladder cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post Treatment Pathological Staging
Secondary outcome measures
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 • NCT0220963638%
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
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
~2240
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,145 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,737 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to get out of my bed or chair and move around.I am not pregnant or breastfeeding.I agree to use specified birth control methods if I or my partner can become pregnant.You currently use tobacco products.I have a history of G6PD deficiency.I do not have any uncontrolled illnesses.I have had chemotherapy or radiation therapy for bladder issues before.I cannot receive cisplatin and have muscle invasive bladder cancer.My bladder cancer is of a specific type (adenocarcinoma, squamous cell, or small cell).My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: IV Ascorbic Acid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some Ascorbic Acid benefits?
"Ascorbic Acid, more commonly known as Vitamin C, can be used to treat conditions such as a deficiency in Vitamin A, or Catarrh. Additionally, it is often taken as a supplement to ensure an individual has enough vitamins in their system."
Answered by AI
How many participants are helping researchers with this experiment?
"Although this study was updated recently on September 21st, 2022, it is not currently seeking patients. There are, however, 393 other cancer trials and 56 Ascorbic Acid trials that are recruiting."
Answered by AI
Can patients still sign up for this experiment?
"Though this study was posted on October 17th, 2019 and last edited September 21st, 2022, it is not recruiting patients at this time. However, there are presently 393 trials actively searching for patients with bladder cancer and 56 studies for Ascorbic Acid that need participants."
Answered by AI
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