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

University of Kansas

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Bladder Cancer

Treatments

Drug: Ascorbic Acid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04046094

UL1TR002366 (U.S. NIH Grant/Contract)

IIT-2019-IVC_CarboGem

Details and patient eligibility

About

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.

Full description

see protocol

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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