IV Vitamin C + Chemotherapy for Bladder Cancer

Recruiting at 2 trial locations

Overseen By Clinical Trials Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Kansas Medical Center

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients. However, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. Although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by NAC. Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. This trial will add IVC to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.

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.

What data supports the effectiveness of the treatment Ascorbic Acid combined with chemotherapy for bladder cancer?

Some studies suggest that vitamin C, when combined with other vitamins like K3, may help make bladder cancer cells more sensitive to chemotherapy. However, there is no strong evidence that vitamin C alone can prevent or treat bladder cancer effectively. ^{1 2 3 4 5}

How does the treatment of IV Vitamin C combined with chemotherapy differ from other bladder cancer treatments?

This treatment is unique because it combines intravenous (IV) Vitamin C with chemotherapy, potentially enhancing the effectiveness of chemotherapy by using Vitamin C as a sensitizing agent, which may make cancer cells more responsive to the treatment. This approach is different from standard treatments that typically do not include high doses of Vitamin C administered directly into the bloodstream. ^{1 2 3 6 7}

Research Team

John Taylor, MD MS

Principal Investigator

The University of Kansas

Eligibility Criteria

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

I am able to get out of my bed or chair and move around.

I agree to use specified birth control methods if I or my partner can become pregnant.

I cannot receive cisplatin and have muscle invasive bladder cancer.

Exclusion Criteria

Current or anticipated use of other investigational agents while participating in this study

I am not pregnant or breastfeeding.

You currently use tobacco products.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV Ascorbic Acid 25 grams infused 2 times a week for 4 weeks alongside gemcitabine/carboplatin chemotherapy

4 weeks

8 visits (in-person)

Post-treatment Evaluation

Post treatment specimen pathology results evaluated per the WHO TNM staging system

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

6 weeks

Long-term Follow-up

Disease Free Survival Rate (DFS) monitored among participants

5 years

Treatment Details

Interventions

• Ascorbic Acid

Trial Overview 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.

Participant Groups

Group I: IV Ascorbic Acid Experimental Treatment 1 Intervention

IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Vitamins C and K3 sensitize human urothelial tumors to gemcitabine. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Vitamin C and vitamin E supplement use and bladder cancer mortality in a large cohort of US men and women. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Failure of ascorbic acid to inhibit FANFT-induced bladder cancer. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Study of blood vitamin C in lung and bladder cancer patients before and after treatment with ascorbic acid. A preliminary report. [2013]

5. Italy pubmed.ncbi.nlm.nih.gov

[Vitamin C. Its clinical use and state of the art]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Promotion by L-ascorbic acid of urinary bladder carcinogenesis in rats under conditions of increased urinary K ion concentration and pH. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Promoting effects of sodium L-ascorbate on two-stage urinary bladder carcinogenesis in rats. [2013]