Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
18 Years
N/A
Both
Blood And Marrow Transplantation
Trial Information
Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
Study Drug Administration:
If patient is found to be eligible to take part in this study, on Day 1, cidofovir will be
put into the bladder through the foley catheter. The catheter will be clamped shut for 2
hours to keep the drug inside patient's bladder. After 2 hours, the catheter will be
unclamped so that the drug may drain out. If patient was receiving bladder irrigation (where
the bladder is flushed with water) as therapy for hemorrhagic cystitis, this therapy will be
restarted after their dose of cidofovir.
Pharmacokinetic (PK) and Pharmacodynamic (PD) Testing:
On Day 1, blood (about 2 teaspoons each time) will be drawn for PK and PD testing before the
dose, 2 times during the dose, and 4 more times over the next 20 hours (+/- 1 hour) after
the dose. PK testing measures the amount of study drug in the body at different time
points. PD testing measures how the level of study drug in the body may affect the disease.
Virus Testing:
During this study, extra urine and leftover blood will be collected and used for research to
test for certain viruses, including the type of infection patient had when they joined this
study.
Before and after the cidofovir dose on Day 1, and again on Day 4, urine will be collected
for virus testing.
Any blood left over from Day 1 testing will also be used for virus testing.
Length of Study Participation:
Patient's active study participation will be over after the Day 14 follow-up visit (below).
If patient experiences a side effect, the study staff will continue checking their medical
records until the side effect becomes stable or gets better.
Follow-Up:
On Days 3 and 7, blood (about 2 teaspoons) will be drawn for routine tests.
On Day 7 (+/- 2 days):
- Patient's vital signs will be measured, and they will be asked about any symptoms they
may be having.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Blood (about ½ teaspoon) will be drawn for PK testing.
- Urine will be collected for routine tests.
On Day 14 (+/- 2 days):
- Patient will be asked about any symptoms they may be having.
- Blood (about ½ teaspoon) will be drawn for PK testing.
- Urine will be collected for routine tests.
On Day 30 (+/- 2 days), patient will be contacted by phone and asked about any side effects
they may be having. This call will take about 10 minutes.
This is an investigational study. Cidofovir given by injection is commercially available
and FDA approved to treat CMV in patients with HIV. Its use in this study is
investigational.
Up to 6 patients will take part in this study. All will be enrolled at MD Anderson.
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 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 >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 % 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Systemic Absorption of Cidofovir
Outcome Description:
Systemic absorption of drug evaluated during and after intravesical administration. Blood collected for each sample in the following schedule: T0 (pre-instillation) 1 hour (after instillation) 2 hours (after instillation-at the time of de-clamping) 4 hours +/- 1 hour (after instillation) 14 hours +/- 1 hour (14 hours after instillation or 12 hours from de-clamping). 24 hours +/- 1 hour after instillation to ensure complete characterization of cidofovir elimination.
Outcome Time Frame:
7 days
Safety Issue:
No
Principal Investigator
Roy F. Chemaly, MD, MPH, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2012-0903
NCT ID:
NCT01816646
Start Date:
September 2013
Completion Date:
Related Keywords:
- Blood And Marrow Transplantation
- Blood And Marrow Transplantation
- Hemorrhagic Cystitis
- Bleeding from bladder
- Foley catheter
- Cystitis
Name | Location |
|---|---|
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
