Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients

Bladder Cancer Clinical Trial

Official title:

IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04046094
• Other study ID #: IIT-2019-IVC_CarboGem
• Secondary ID: UL1TR002366
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 17, 2019
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

see protocol

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: August 2024
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Uncontrolled intercurrent illness

• Current consumption of tobacco products

• History of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Ascorbic Acid
Ascorbic Acid Intravenous

Locations

Country	Name	City	State
United States	The University of Kansas Cancer Center (KUCC)	Fairway	Kansas
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks after first IVC infusion at radical cystectomy
Secondary	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".	Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)
Secondary	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.	5 years