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

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ClinicalTrials.gov Identifier: NCT04046094
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
John Taylor, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Ascorbic Acid Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IV Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients: A Forgotten Group
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


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 Name: Vitamin C




Primary Outcome Measures :
  1. Post Treatment Pathological Staging [ Time Frame: 10 weeks ]
    Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines


Secondary Outcome Measures :
  1. Overall change in patient-reported quality of life outcomes [ Time Frame: 8 weeks ]

    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".

  2. Disease free survival rate (DFS) among participants [ Time Frame: 5 years ]
    Medical Record



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046094


Contacts
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Contact: Clinical Trials Nurse Navigator 913-945-7552 ctnursenav@kumc.edu

Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: John Taylor, MD MS The University of Kansas

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Responsible Party: John Taylor, Professor, Director of Basic Urologic Research, Co-Leader of D3ET, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04046094     History of Changes
Other Study ID Numbers: IIT-2019-IVC_CarboGem
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Taylor, University of Kansas Medical Center:
Intravenous (IV) Ascorbic Acid (Vitamin C)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Vitamins
Ascorbic Acid
Cisplatin
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents