Intravesical Cidofovir for Hemorrhagic Cystitis

NCT01816646 | Completed Phase 1

• 2 other identifiers: 2012-0903NCI-2013-02184
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose directly into the bladder is absorbed by the body. Researchers also want to measure the amount of study drug in the body at different time points. The safety and tolerability of this drug will also be studied. Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.

Conditions

Blood And Marrow Transplantation

Keywords

Blood And Marrow Transplantation; Hemorrhagic Cystitis; Bleeding from bladder; Foley catheter; Probenecid; Cidofovir; Vistide

Outcome Measures

Primary Outcomes (1)

• Systemic Absorption of Cidofovir

  Systemic absorption of drug evaluated during and after intravesical administration. Blood collected for each sample in the following schedule: 1. T0 (pre-instillation) 2. 1 hour (after instillation) 3. 2 hours (after instillation-at the time of de-clamping) 4. 4 hours +/- 1 hour (after instillation) 5. 14 hours +/- 1 hour (14 hours after instillation or 12 hours from de-clamping). 6. 24 hours +/- 1 hour after instillation to ensure complete characterization of cidofovir elimination.

  7 days

Study Arms (1)

Cidofovir

EXPERIMENTAL

Patients receive a single dose of 2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours. Probenecid 2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.

Drug: Cidofovir; Drug: Probenecid

Interventions

Cidofovir DRUG

2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours.

Also known as: Vistide

Cidofovir

Probenecid DRUG

2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.

Cidofovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Polyoma BK or adenovirus viruria has been established either by positive urine cytology or by PCR for BK virus or by positive urine culture for adenovirus.
• The patient has either gross hematuria and/or passes blood clots.
• Signed informed consent form containing all potential serious adverse events related to cidofovir use as given on the package insert.
• Hospitalized patients with a Foley catheter.
• Women of childbearing potential (Women who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy) must agree to use 2 acceptable methods of birth control (e. g., barrier method (such and condom or diaphragm) and another form, such as an intrauterine device (IUD) or hormonal birth control, during the study period and for a period of 2 months afterward. Males must also agree to use an acceptable method of birth control (barrier method) during the study period and for 2 months afterward.

You may not qualify if:

• Serum creatinine \>2 mg/dl and/or calculated creatinine clearance \< 50 ml/min using the Cockcroft-Gault Creatinine Clearance formula (CrCl). CrCl = {(140-Age) x Weight (kgs) x 0.85 (if female)}/ {72x Serum Creatinine (mg/dl)}
• Urine protein \> 100 mg/dl (equivalent to \> 2+ proteinuria)
• Age less than 18 years.
• Prior therapy with formalin or carboprost 1 mg/dL administered intravesically.
• Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
• Patients who have received prior cidofovir therapy within 2 weeks
• Prior enrollment in the study
• Women who are pregnant or breast-feeding
• Evidence of end-organ adenoviral infection

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Aitken SL, Zhou J, Ghantoji SS, Kontoyiannis DP, Jones RB, Tam VH, Chemaly RF. Pharmacokinetics and safety of intravesicular cidofovir in allogeneic HSCT recipients. J Antimicrob Chemother. 2016 Mar;71(3):727-30. doi: 10.1093/jac/dkv393. Epub 2015 Nov 26.

  PMID: 26612873 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Cystitis, Hemorrhagic

Interventions

Cidofovir; Probenecid

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds

Study Officials

• Roy F. Chemaly, MD, MPH, MBA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (1)