Overview

Intravesical Cidofovir for Hemorrhagic Cystitis

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Gilead Sciences
Treatments:
Cidofovir
Probenecid
Criteria
Inclusion Criteria:

1. 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.

2. The patient has either gross hematuria and/or passes blood clots.

3. Signed informed consent form containing all potential serious adverse events related
to cidofovir use as given on the package insert.

4. Hospitalized patients with a Foley catheter.

5. 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 Criteria:

1. 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)}

2. Urine protein > 100 mg/dl (equivalent to > 2+ proteinuria)

3. Age less than 18 years.

4. Prior therapy with formalin or carboprost 1 mg/dL administered intravesically.

5. Hypersensitivity to cidofovir, probenecid or sulfa-containing medications

6. Patients who have received prior cidofovir therapy within 2 weeks

7. Prior enrollment in the study

8. Women who are pregnant or breast-feeding

9. Evidence of end-organ adenoviral infection