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

February 28, 2024 updated by: John Taylor, University of Kansas Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

see protocol

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas Cancer Center (KUCC)
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66205
        • The University of Kansas Cancer Center, Westwood Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV Ascorbic Acid
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks
Drug: Ascorbic Acid
Ascorbic Acid Intravenous
Other Names:
  • Vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Treatment Pathological Staging
Time Frame: 6 weeks after first IVC infusion at radical cystectomy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Change in Patient-reported Quality of Life Outcomes
Time Frame: Baseline, End of Treatment (completion of neoadjuvant therapy, Day 28), Post-surgery (6 weeks post-operative)

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)
Disease Free Survival Rate (DFS) Among Participants
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: John Taylor, MD MS, The University of Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2019

Primary Completion (Actual)

September 12, 2022

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2019-IVC_CarboGem
  • UL1TR002366 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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