A Phase 1/2 interventional study of Ascorbic Acid in Bladder Cancer, sponsored by University of Kansas Medical Center. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by University of Kansas Medical Center · Phase 1/2, Interventional, and Treatment
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.
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1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks
Drug: Ascorbic Acid
Ascorbic Acid Intravenous
Also known as: Vitamin C
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.
Time frame: 6 weeks after first IVC infusion at radical cystectomy
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".
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
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.
Time frame: 5 years
| Milestone | IV Ascorbic Acid |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| Participants | IV Ascorbic Acid |
|---|---|
| Stage 0 | 3 |
| Stage I | 2 |
| Stage II | 1 |
| Stage III | 4 |
| Stage IV | 2 |
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".
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Ascorbic Acid | 4/12 (33.3%) | 2/12 (16.7%) | 0/12 (0%) |
| Event | IV Ascorbic Acid |
|---|---|
| IleusGastrointestinal disorders | 2/12 |
| Age, Categorical(Participants) | IV Ascorbic Acid |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 11 |
| Age, Continuous(years) | IV Ascorbic Acid |
|---|---|
| Mean | 76.3 ± 9.4 |
| Sex: Female, Male(Participants) | IV Ascorbic Acid |
|---|---|
| Female | 3 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | IV Ascorbic Acid |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | IV Ascorbic Acid |
|---|---|
| United States | 12 |
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University of Kansas Medical Center