Clinical trial NCT04046094: Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
Official title: IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Bladder Cancer
Keywords: Intravenous (IV) Ascorbic Acid (Vitamin C)
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-08-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Post Treatment Pathological Staging
timeFrame: 6 weeks after first IVC infusion at radical cystectomy
Secondary outcomes:
measure: Overall Change in Patient-reported Quality of Life Outcomes
timeFrame: Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)
measure: Disease Free Survival Rate (DFS) Among Participants
timeFrame: 5 years
Other outcomes:
Locations:
city: Fairway
country: United States
facility: The University of Kansas Cancer Center (KUCC)
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
affiliation: The University of Kansas
name: John Taylor, MD MS
role: PRINCIPAL_INVESTIGATOR
References: