Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Gilead Sciences
Treatments:
Cidofovir
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 and/or blood culture for
adenovirus

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

3. Signed informed consent form

4. Hospitalized patients with a Foley catheter

5. 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:

1. 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)}

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 % administered intravesically

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

6. 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