IV Vitamin C + Chemotherapy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding high doses of vitamin C (ascorbic acid) to chemotherapy can more effectively combat bladder cancer. It targets individuals with muscle-invasive bladder cancer who cannot use the usual cisplatin chemotherapy due to health issues. Instead, they will receive a combination of vitamin C and other chemotherapy drugs, carboplatin and gemcitabine, to assess improvements in treatment outcomes. Individuals with bladder cancer who cannot receive cisplatin and have no major health problems might be suitable for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot use other investigational agents while participating in this study.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that receiving vitamin C through an IV is generally safe. Studies have found that high doses administered this way are usually well-tolerated in various cancer treatments, with most people experiencing no serious side effects. In some studies, vitamin C was used alongside regular cancer treatments and remained safe.
Some research suggests that high doses of vitamin C can target cancer cells without harming normal cells. This is promising because it might mean the treatment is gentler on the body. However, safety can vary among individuals, so consulting a healthcare professional before joining a trial is important.12345Why do researchers think this study treatment might be promising for bladder cancer?
Unlike the standard treatments for bladder cancer, which typically involve chemotherapy drugs like cisplatin or gemcitabine, this investigational approach involves high doses of vitamin C, known as ascorbic acid, delivered directly into the bloodstream. Researchers are excited because this delivery method allows for much higher concentrations of vitamin C, which may enhance the effectiveness of chemotherapy by acting as a pro-oxidant that selectively targets cancer cells. This approach is unique because it potentially boosts the cancer-fighting power of traditional treatments while minimizing damage to healthy cells.
What evidence suggests that IV Vitamin C could be an effective treatment for bladder cancer?
Research has shown that high-dose intravenous (IV) vitamin C may help fight cancer by attacking cancer cells, altering their genes, and strengthening the immune system. In previous studies, this treatment reduced tumor size in about one-third of bladder cancer patients before surgery. In this trial, participants will receive IV vitamin C as an experimental treatment. Some early evidence suggests that adding IV vitamin C to chemotherapy can enhance its effectiveness. These findings offer hope for patients unable to use standard treatments.12467
Who Is on the Research Team?
John Taylor, MD MS
Principal Investigator
The University of Kansas
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IV Ascorbic Acid 25 grams infused 2 times a week for 4 weeks alongside gemcitabine/carboplatin chemotherapy
Post-treatment Evaluation
Post treatment specimen pathology results evaluated per the WHO TNM staging system
Follow-up
Participants are monitored for safety and effectiveness after treatment, including quality of life assessments
Long-term Follow-up
Disease Free Survival Rate (DFS) monitored among participants
What Are the Treatments Tested in This Trial?
Interventions
- Ascorbic Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator