Vitamin C + Chemotherapy for Bladder Cancer

Recruiting at 1 trial location

Overseen By Faith Rahman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must be taking: Gemcitabine, Carboplatin

Must not be taking: Antineoplastics, Investigational agents

Disqualifiers: Pregnancy, Psychiatric illness, Infections, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Eligibility Criteria

This trial is for patients with muscle invasive bladder cancer who can't have cisplatin or choose not to. It's a phase II study, meaning it's checking the effectiveness and safety of adding high-dose vitamin C (IVC) to standard chemo drugs gemcitabine and carboplatin.

Inclusion Criteria

Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment

Ability of participant to understand this study, and participant willingness to sign a written informed consent

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

Has a severe known allergic reaction to any excipient contained in the study drug formulation

I currently use tobacco but can quit for 2 weeks before joining.

If tobacco use is suspected at any point during the trial, cotinine level will be obtained

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two cycles of gemcitabine/carboplatin along with intravenous vitamin C

4 weeks

Multiple visits for drug administration

Surgery

Participants proceed to cystectomy after treatment

Approximately 10 to 12 weeks from initial diagnosis

Follow-up

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

10 to 16 weeks

Long-term Follow-up

Participants are monitored for disease-free survival and disease-specific survival

2 years

Treatment Details

Interventions

• Intravenous Ascorbic Acid

Trial Overview The trial tests whether intravenous ascorbic acid (high-dose vitamin C) combined with gemcitabine/carboplatin chemotherapy can be an effective treatment that also improves quality of life for those with muscle invasive bladder cancer who aren't using cisplatin.

Participant Groups

Group I: Intravenous ascorbic acid/vitamin C Experimental Treatment 1 Intervention

2 Cycles Carboplatin Day 1 and Gemcitabine Days 1 and 8 (NAC) + Intravenous Vitamin C Days 1-28

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+