IV Vitamin C + Chemotherapy for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJohn Taylor, MD MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Kansas Medical Center

Stay on Your Current Meds

No Placebo Group

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.

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.

+1 more

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.

+6 more

Participant Groups

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.

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