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

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To assess pathologic downstaging rate in MIBC cisplatinineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IV Ascorbic Acid

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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

Ascorbic Acid Intravenous

Interventions

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Ascorbic Acid

Ascorbic Acid Intravenous

Intervention Type DRUG

Other Intervention Names

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Vitamin C

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No