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

Primary Purpose

Bladder Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ascorbic Acid
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Intravenous (IV) Ascorbic Acid (Vitamin C)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Kansas Cancer Center (KUCC)
  • The University of Kansas Medical Center
  • The University of Kansas Cancer Center, Westwood Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV Ascorbic Acid

Arm Description

IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks

Outcomes

Primary Outcome Measures

Post Treatment Pathological Staging
Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines

Secondary Outcome Measures

Overall change in patient-reported quality of life outcomes
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".
Disease free survival rate (DFS) among participants
Medical Record

Full Information

First Posted
August 2, 2019
Last Updated
September 21, 2022
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04046094
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Intravenous (IV) Ascorbic Acid (Vitamin C)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Ascorbic Acid
Arm Type
Experimental
Arm Description
IV Ascorbic Acid 25 grams (g) infused 2 times a week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C
Intervention Description
Ascorbic Acid Intravenous
Primary Outcome Measure Information:
Title
Post Treatment Pathological Staging
Description
Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Overall change in patient-reported quality of life outcomes
Description
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".
Time Frame
8 weeks
Title
Disease free survival rate (DFS) among participants
Description
Medical Record
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Taylor, MD MS
Organizational Affiliation
The University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Cancer Center (KUCC)
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The University of Kansas Cancer Center, Westwood Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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