Bladder CancerPhase 1/2NCT04046094
Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
A Phase 1/2 study testing Ascorbic Acid in people with Bladder Cancer, run by University of Kansas Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Oct 2019to Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
- Cisplatin-ineligible, muscle invasive bladder cancer
- Adequate organ and marrow functions
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control
Who cannot join
- Patient simultaneously enrolled in any therapeutic clinical trial
- Current or anticipated use of other investigational agents while participating in this study
- Psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
- Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
- Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder
Show all 9Show fewer
- Uncontrolled intercurrent illness
- Current consumption of tobacco products
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, 66205
The University of Kansas Medical Center
Kansas City, Kansas, 66160
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
About this study
Official title: IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
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.
Read the detailed description
see protocol
- Conditions
- Bladder Cancer
- Being tested
- Ascorbic Acid
- Keywords
- Intravenous (IV) Ascorbic Acid (Vitamin C)
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C
Ascorbic Acid Intravenous
| Study group | Role | What they receive |
|---|---|---|
| IV Ascorbic Acid | Experimental | IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Treatment Pathological Staging
Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.
Measured: 6 weeks after first IVC infusion at radical cystectomy
Secondary outcomes (2)
Overall Change in Patient-reported Quality of Life Outcomes
Scores evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores:
- FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL.
- FACT-Bl includes five sub-scales:
- Physical Well-being (PWB), score range of 0-28
- Social/Family Well-being (SWB), score range of 0-28
- Emotional Well-being (EWB), score range of 0-24
- Functional Well-being (FWB), score range of 0-28
- Bladder Cancer Subscale (BlCS), score range of 0-48
- Note: Negatively stated items are reversed by subtracting the response from "4".
Measured: Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)
Disease Free Survival Rate (DFS) Among Participants
DFS will be defined as time from cystectomy to disease recurrence or death resulting from disease. DFS represents time from random assignment to cancer recurrence or death from any cause. Patients alive without disease progression at the time of analysis were censored at the date of last disease assessment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start17 Oct 2019
- Primary completion12 Sep 2022
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, John Taylor, University of Kansas Medical Center
- Investigators
- John Taylor, MD MS, Principal investigator, The University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046094
- Sponsor's protocol ID
- IIT-2019-IVC_CarboGem
- Other IDs
- UL1TR002366
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
- ClinicalTrials.gov ID
- NCT04046094
- Acronym / sponsor ID
- IIT-2019-IVC_CarboGem
- Conditions
- Bladder Cancer
- Keywords
- Intravenous (IV) Ascorbic Acid (Vitamin C)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
see protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.
| Arm | Type | Receives |
|---|---|---|
| IV Ascorbic Acid | Experimental | Drug: Ascorbic AcidIV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
- Cisplatin-ineligible, muscle invasive bladder cancer
- Adequate organ and marrow functions
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control
Key exclusion criteria (9 listed)
- Patient simultaneously enrolled in any therapeutic clinical trial
- Current or anticipated use of other investigational agents while participating in this study
- Psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
- Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin CAscorbic Acid Intravenous | Drug | IV Ascorbic Acid |
Primary outcome
Post Treatment Pathological Staging
Time frame: 6 weeks after first IVC infusion at radical cystectomy
Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.
2 secondary outcomes
Overall Change in Patient-reported Quality of Life Outcomes
Time frame: Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)
Disease Free Survival Rate (DFS) Among Participants
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Taylor, MD MS principal investigator
The University of Kansas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ascorbic Acid in people with Bladder Cancer, run by University of Kansas Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Treatment Pathological Staging (time frame: 6 weeks after first IVC infusion at radical cystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.