CystitisNCT00956176
Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
A study testing Cidofovir in people with Cystitis and Bladder Diseases, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystitis, Bladder Diseases
- What is being tested?
- Cidofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- The patient has either gross hematuria and/or passes blood clots
- Signed informed consent form
- Hospitalized patients with a Foley catheter
- 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.
Who cannot join
- 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)}
- Urine protein > 100 mg/dl (equivalent to > 2+ proteinuria)
- Age less than 18 years
- Prior therapy with formalin or carboprost 1 mg % administered intravesically
- Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
- Have received prior cidofovir therapy within 2 weeks.
Show all 9Show fewer
- Prior enrollment in the study
- Women who are pregnant or breast-feeding
- Evidence of end-organ adenoviral infection
About this study
Official title: Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
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.
Read the detailed description
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.
- Conditions
- Cystitis, Bladder Diseases
- Being tested
- Cidofovir
- Keywords
- Cidofovir, Vistide, Adenovirus, BK virus infections, HSCT, Hemorrhagic Cystitis, Foley catheter, Viral infection, Bladder instillation, Intravesical, Transurethral catheter, Transplantation
- Medical subject headings
- Cystitis, Urinary Bladder Diseases, Adenoviridae Infections, Cystitis, Hemorrhagic, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CidofovirDrug
Also called Vistide
Single dose of 5 mg/kg administered in 100 ml of normal saline solution through a foley catheter to bladder. The catheter will be clamped for 2 hours to keep the drug in bladder.
| Study group | Role | What they receive |
|---|---|---|
| Cidofovir | Experimental | Not described Receives: Drug: Cidofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Absorption of Cidofovir via bladder instillation
Measured: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Roy F. Chemaly, MD, MPH, MBA, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956176
- Sponsor's protocol ID
- 2007-0040
- Status last verified
- May 2019
- First submitted
- 7 Aug 2009
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT00956176
- Acronym / sponsor ID
- 2007-0040
- Conditions
- Cystitis, Bladder Diseases
- Keywords
- Cidofovir, Vistide, Adenovirus, BK virus infections, HSCT, Hemorrhagic Cystitis, Foley catheter, Viral infection
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cidofovir | Experimental | Drug: Cidofovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- The patient has either gross hematuria and/or passes blood clots
- Signed informed consent form
- Hospitalized patients with a Foley catheter
- 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.
Key exclusion criteria (9 listed)
- 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)}
- Urine protein > 100 mg/dl (equivalent to > 2+ proteinuria)
- Age less than 18 years
- Prior therapy with formalin or carboprost 1 mg % administered intravesically
- Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CidofovirAlso: VistideSingle dose of 5 mg/kg administered in 100 ml of normal saline solution through a foley catheter to bladder. The catheter will be clamped for 2 hours to keep the drug in bladder. | Drug | Cidofovir |
Primary outcome
Systemic Absorption of Cidofovir via bladder instillation
Time frame: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy F. Chemaly, MD, MPH, MBA principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Cidofovir in people with Cystitis and Bladder Diseases, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Absorption of Cidofovir via bladder instillation (time frame: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.