Status:
WITHDRAWN
Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
Cystitis
Bladder Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
The Study Drug: Cidofovir is designed to fight CMV (a viral infection) by blocking the CMV cells from dividing. Cidofovir is commonly given by injection. For research purposes, in this study it will...
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 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
- 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
- Evidence of end-organ adenoviral infection
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00956176
Last Update
May 14 2019
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