WithdrawnNot Applicable

Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis

Plain-language summary

The goal of this clinical research study is to learn how the body absorbs and processes 1 dose of cidofovir that is given directly into the bladder, in patients with a viral infection that is causing bleeding from the bladder. The safety of this drug dose and the investigational way it is given (directly into the bladder) will also be studied.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Polyoma BK or adenovirus viruria has been established either by positive urine cytology or by PCR for BK virus or by positive urine and/or blood culture for adenovirus
✓. The patient has either gross hematuria and/or passes blood clots
✓. Signed informed consent form
✓. Hospitalized patients with a Foley catheter
✓. Women of childbearing potential must agree to use 2 acceptable methods of birth control (e. g., abstinence, IUD, or barrier method), during the study period and one for a period of 2 months afterward. At least one of the methods must be a barrier method. Males must also agree to use acceptable method of birth control (barrier method) during the study period and for 2 months afterward.

Exclusion criteria

✕. Serum creatinine \>1.5 mg/dl and/or calculated creatinine clearance \< 55 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 % administered intravesically
✕. Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
✕. Have received prior cidofovir therapy within 2 weeks.
✕. Prior enrollment in the study
✕. Women who are pregnant or breast-feeding

What they're measuring

Systemic Absorption of Cidofovir via bladder instillation

Timeframe: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.

Trial details

NCT IDNCT00956176

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Cystitis trials