IV Vitamin C with Gemcitabine/Carboplatin for Bladder Cancer

Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer

Recruiting Phase 2 Interventional Study
Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
University of Kansas Medical Center · Other
Who this trial is looking for

This trial is looking for patients with muscle invasive bladder cancer who cannot receive cisplatin or choose not to. Participants will receive a treatment combining intravenous vitamin C with other medications and share their health experiences during the trial.

Are You a Good Fit for This Trial?
Rules you out Severe allergic reactionPregnancyUncontrolled infectionSevere psychiatric illnessActive heart or lung disease

You may be able to join if

  • I am at least 18 years old.
  • I have muscle invasive bladder cancer and cannot receive cisplatin or choose not to.
  • I understand the study and agree to participate.
  • I have good organ function as defined by the study.
  • I am willing to provide consent for a biorepository protocol.
  • I can practice contraception if I am of childbearing potential.

You may not be able to join if

  • I am currently in another clinical trial.
  • I am pregnant or breastfeeding.
  • I have a severe allergy to any ingredient in the study drugs.
  • I have an uncontrolled medical condition that may affect the study.
  • I have a psychiatric illness that limits my ability to follow the study.
  • I have a history of tobacco use during the trial.
  • I have active infections within the last 2 weeks.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent * Consent to participate in biorepository protocol number GUB-BCR-001, KU IRB Approved HSC # STUDY00141546 * Males and females age ≥ 18 years * ECOG Performance Stat…
Contacts

KUCC Navigation

913-588-3671

kucc_navigation@kumc.edu

CONTACT

Faith Rahman

913-588-2502

frahman2@kumc.edu

CONTACT