Overview
Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
Status:
Withdrawn
Withdrawn
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterCollaborator:
Gilead SciencesTreatments:
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