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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding high doses of intravenous Vitamin C (Intravenous Ascorbic Acid) to standard chemotherapy can better treat bladder cancer in patients who cannot or choose not to use cisplatin, a common chemotherapy drug. The researchers aim to determine if this combination can shrink the cancer and improve patients' quality of life. Suitable candidates include those with muscle-invasive bladder cancer who cannot or do not want to use cisplatin. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use other anti-cancer or investigational drugs while participating in this study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that high-dose vitamin C administered through an IV is generally safe. Early studies on various cancer types have confirmed its safety in this form. Some reports even suggest that cancer patients lived longer than expected after receiving high doses of vitamin C intravenously.

Additionally, a previous study focused on bladder cancer patients who couldn't use the common chemotherapy drug cisplatin. This study tested IV vitamin C with other chemotherapy drugs and found no major safety issues, indicating that most patients can tolerate IV vitamin C well.

In summary, earlier studies suggest that high-dose IV vitamin C is a promising and safe treatment option for cancer patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using intravenous Vitamin C alongside chemotherapy for bladder cancer because it introduces a potentially powerful combination. Traditional treatments for bladder cancer typically involve chemotherapy drugs like carboplatin and gemcitabine. However, adding intravenous Vitamin C could enhance the effectiveness of these drugs. Vitamin C is believed to work as an antioxidant and might help reduce the harmful effects of cancer therapy on healthy cells while boosting the impact on cancer cells. This unique approach could improve the overall treatment results and quality of life for patients.

What evidence suggests that this treatment might be an effective treatment for bladder cancer?

Research has shown that high-dose vitamin C given through an IV might help treat cancer. In this trial, participants will receive chemotherapy with gemcitabine and carboplatin, combined with intravenous vitamin C. An earlier study found that adding vitamin C to chemotherapy reduced tumor size in up to one-third of patients before surgery. Vitamin C seems to work by directly attacking cancer cells and enhancing the effectiveness of chemotherapy drugs like gemcitabine and carboplatin. It also targets tumors by killing cancer stem cells and supporting the immune system. These early results suggest that vitamin C could enhance the effectiveness of chemotherapy for bladder cancer. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8557029/

High-dose intravenous vitamin C, a promising multi-targeting ...

Mounting evidence indicates that vitamin C has the potential to be a potent anti-cancer agent when administered intravenously and in high doses (high-dose IVC).

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06493370

Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A ...

Intravenous ascorbic acid/vitamin C. 2 Cycles Carboplatin Day 1 ... Vitamin C preferentially kills cancer stem cells in hepatocellular carcinoma via SVCT-2.

3.

kucancercenter.org

kucancercenter.org/news-room/news/2024/08/new-study-aims-to-improve-bladder-cancer-treatment-with-high-dose-intravenous-vitamin-c

New Study Aims to Improve Bladder Cancer Treatment ...

Results from their phase I trial showed that this combination shrunk tumor size in up to one-third of patients before surgery. In addition, this ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352304225002314

High-dose vitamin C: A promising anti-tumor agent, insight ...

High-dose vitamin C exhibits selective anti-tumor effects, including pro-oxidative cytotoxicity, anti-cancer epigenetic regulation, and immune modulation.

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04046094/intravenous-iv-vitamin-c-with-chemotherapy-for-cisplatin-ineligible-bladder-cancer-patients

Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin ...

Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC1405876/

Intravenously administered vitamin C as cancer therapy

The authors reviewed 3 cases of advanced cancer where patients had unexpectedly long survival times after receiving high-dose intravenous vitamin C therapy.

7.

jeccr.biomedcentral.com

jeccr.biomedcentral.com/articles/10.1186/s13046-021-02134-y

High-dose intravenous vitamin C, a promising multi-targeting ...

Mounting evidence indicates that vitamin C has the potential to be a potent anti-cancer agent when administered intravenously and in high doses (high-dose IVC).

8.

frederick.cancer.gov

frederick.cancer.gov/node/7313

Intravenous High-Dose Vitamin C in Cancer Therapy

In a follow up study, Cameron and Pauling reported that 22% of vitamin C-treated cancer patients survived for more than one year compared to ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04046094?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Bladder%20Cancer%22)%20AND%20AREA%5BInterventionSearch%5D(%22micronutrients%22)))&rank=6&tab=results

Study Results | NCT04046094 | Intravenous (IV) Vitamin C ...

Also called a data safety and monitoring board, or DSMB. ... Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients.