Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
18 Years
N/A
Both
Cystitis, Bladder Diseases
Trial Information
Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
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 be
given directly into the bladder through a foley catheter. This is one of the first studies
where cidofovir is being given this way in humans.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1, Cidofovir will be put
into your bladder through your foley catheter. The catheter will be clamped for 2 hours to
keep the drug in your bladder. After 2 hours, the catheter will be unclamped. If you were
receiving bladder irrigation as therapy for your hemorrhagic cystitis, this will be
restarted.
Study Tests on Day 1:
On the day you receive cidofovir, blood (about 2 teaspoons) will be drawn 6 times. The
first blood draw will occur before the cidofovir dose, and the last blood draw will occur 24
hours (+/- 1 hour) after the start of the dose. This blood will be used for pharmacokinetic
(PK) and pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the
body at different time points. PD testing is used to look at how the level of study drug in
your body may affect the disease.
Viral Load Testing:
During this study, extra urine and leftover blood to be collected and used for research to
test for certain viruses. These viruses include the type of infection you had when joining
this study, as well as cytomegalovirus (CMV) and another type of herpes virus.
The urine samples will be collected before the cidofovir dose on Day 1, after the cidofovir
dose on Day 1, and again on Day 4.
Any blood left over from Day 1 testing will also be used for viral load testing.
It is possible that these urine and/or blood samples will be sent to an outside lab to
perform this testing. If that occurs, your name and any personal identifying information
will be coded before the samples are sent. Coding the samples is designed to protect your
privacy.
Follow-Up Tests:
Blood (about 2 teaspoons) will be drawn for routine tests 2 times during the week after your
cidofovir dose.
On Day 7 (+/- 2 days), you will be checked for any side effects that could be related to the
study drug.
In addition, on Day 14 (+/- 2 days), blood samples will be drawn for PK testing, urine will
be collected for routine tests, and your safety data will be recorded.
One final follow-up visit will take place on Day 30 (+/- 2 days). During this visit, the
study staff will record any serious side effects you may be experiencing.
Length of Study Participation:
Your active study participation will be over after the Day 7 follow-up visit (+/- 2 days).
If you experienced a side effect, however, the study staff will continue checking your
medical records until the side effect becomes stable or gets better.
This is an investigational study. Cidofovir given by injection is commercially available
and FDA approved to treat CMV in patients with HIV. It is investigational to give cidofovir
directly into the bladder of patients who have a viral infection causing bleeding in the
bladder.
Up to 6 patients will take part in this study. All will be enrolled at M. D. 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 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Systemic Absorption of Cidofovir via bladder instillation
Outcome Time Frame:
Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.
Safety Issue:
Yes
Principal Investigator
Roy F. Chemaly, MD, MPH, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2007-0040
NCT ID:
NCT00956176
Start Date:
September 2012
Completion Date:
Related Keywords:
- Cystitis
- Bladder Diseases
- Cidofovir
- Vistide
- Adenovirus
- BK virus infections
- HSCT
- Hemorrhagic Cystitis
- Foley catheter
- Viral infection
- Bladder instillation
- Intravesical
- Transurethral catheter
- Transplantation
- Urinary Bladder Diseases
- Cystitis
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