Overview
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-03-01
2022-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The goal of this clinical research study is to learn if adding cidofovir to the standard of care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to standard of care alone. The safety of cidofovir will also be studied.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterTreatments:
Cidofovir
Criteria
Inclusion Criteria:1. HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC
per NCI criteria) and positive BKV in urine >1x103 DNA copies/ml
2. Age >/= 6 years
3. Patient must sign the informed consent document.
Exclusion Criteria:
1. Creatine clearance < 55 ml/min, calculated using ideal body weight (IBW) using
Cockcroft-Gault equation
2. Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
3. Use of cidofovir for bladder instillation
4. Use of formalin or hyperbaric oxygen treatment