Status:
COMPLETED
Intravesical Cidofovir for Hemorrhagic Cystitis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
Blood And Marrow Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
Study Drug Administration: If you are found to be eligible to take part in this study, on Day 1, you may receive some fluid for hydration by vein and then cidofovir will be put into your bladder thro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01816646
Start Date
September 1 2013
End Date
December 1 2016
Last Update
December 6 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030