Intravesical Cidofovir for Hemorrhagic Cystitis

Completed · Phase 1

Conditions studied: Blood And Marrow Transplantation

In brief

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.

Key facts

Study ID

NCT01816646

Run by

M.D. Anderson Cancer Center

People needed

6

Starts

2013-09-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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