Status:
ACTIVE_NOT_RECRUITING
Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
see protocol
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04046094
Start Date
October 17 2019
End Date
August 1 2026
Last Update
March 25 2025
Active Locations (3)
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1
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States, 66205
2
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
3
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205