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Blood And Marrow TransplantationPhase 1NCT01816646

Intravesical Cidofovir for Hemorrhagic Cystitis

A Phase 1 study testing Cidofovir and Probenecid in people with Blood And Marrow Transplantation, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose directly into the bladder is absorbed by the body. Researchers also want to measure the amount of study drug in the body at different time points. The safety and tolerability of this drug will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blood And Marrow Transplantation
What is being tested?
Cidofovir and Probenecid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Sep 2013to Dec 2016
Phase
Phase 1
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 culture for adenovirus.
  • The patient has either gross hematuria and/or passes blood clots.
  • Signed informed consent form containing all potential serious adverse events related to cidofovir use as given on the package insert.
  • Hospitalized patients with a Foley catheter.
  • Women of childbearing potential (Women who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy) must agree to use 2 acceptable methods of birth control (e. g., barrier method (such and condom or diaphragm) and another form, such as an intrauterine device (IUD) or hormonal birth control, during the study period and for a period of 2 months afterward. Males must also agree to use an acceptable method of birth control (barrier method) during the study period and for 2 months afterward.

Who cannot join

  • 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)}
  • Urine protein > 100 mg/dl (equivalent to > 2+ proteinuria)
  • Age less than 18 years.
  • Prior therapy with formalin or carboprost 1 mg/dL administered intravesically.
  • Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
  • Patients who 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

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 drug cidofovir given as 1 dose directly into the bladder is absorbed by the body. Researchers also want to measure the amount of study drug in the body at different time points. The safety and tolerability of this drug will also be studied.

Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.

Read the detailed description

Study Drug Administration:

If you are found to be eligible to take part in this study, on Day 1, you may receive some fluid for hydration by vein and then cidofovir will be put into your bladder through your foley catheter. The catheter will be clamped shut for 2 hours to keep the drug inside your bladder. After 2 hours, the catheter will be unclamped so that the drug may drain out. If you were receiving bladder irrigation (where the bladder is flushed with water) as therapy for hemorrhagic cystitis, this therapy will be restarted after your dose of cidofovir.

Pharmacokinetic (PK) Testing:

On Day 1, blood (about 2 teaspoons each time) will be drawn for PK testing approximately 1 hour (+/- 15 minutes) before the dose, and then again at 1 hour (+/- 15 minutes), 2 hours (+/- 15 minutes), 4 hours (+/- 1 hour), 14 hours (+/- 1 hour) and 24 hours (+/- 1 hour) after the dose. A PK sample will also be drawn on Day 14 (+- 2 days) after the dose. PK testing measures the amount of study drug in the body at different time points.

Virus Testing:

During this study, urine and blood will be collected and used for research to test for certain viruses, including the type of infection you had when you joined this study.

Before and after the cidofovir dose on Day 1, Day 3 (+/- 1 day), Day 7 (+/- 2 days) and again on Day 14 (+/- 2 days) urine and blood (about 1 teaspoon) will be collected for virus testing.

Length of Study Participation:

Your active study participation will be over after the Day 30 follow-up phone call (below). If you experienced a side effect, the study staff will continue checking your medical records until the side effect becomes stable or gets better.

Follow-Up:

On Day 3 (+/- 1 day):

  • You will have a physical exam.
  • Your vital signs will be measured, and you will be asked about any symptoms you may be having.
  • Urine will be collected for routine tests
  • Blood (about 1 teaspoon) will be drawn for routine tests.

On Day 7 (+/- 2 days):

  • You will have a physical exam.
  • Your vital signs will be measured, and you will be asked about any symptoms you may be having.
  • Blood (about 1 teaspoon) will be drawn for routine tests.
  • Urine will be collected for routine tests.

On Day 14 (+/- 2 days):

  • You will be asked about any symptoms you may be having.
  • Blood (about 1 teaspoon) will be drawn for routine tests.
  • Urine will be collected for routine tests.

On Day 30 (+/- 2 days), you will be contacted by phone and asked about any side effects you 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.

Being tested
Cidofovir, Probenecid
Keywords
Blood And Marrow Transplantation, Hemorrhagic Cystitis, Bleeding from bladder, Foley catheter, Probenecid, Cidofovir, Vistide
Medical subject headings
Cystitis, Hemorrhagic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CidofovirDrug

    Also called Vistide

    2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours.

  • ProbenecidDrug

    2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.

Study groups in NCT01816646
Study groupRoleWhat they receive
CidofovirExperimentalPatients receive a single dose of 2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours. Probenecid 2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.
Receives: Drug: Cidofovir; Drug: Probenecid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systemic Absorption of Cidofovir

    Systemic absorption of drug evaluated during and after intravesical administration. Blood collected for each sample in the following schedule:

    1. T0 (pre-instillation)
    2. 1 hour (after instillation)
    3. 2 hours (after instillation-at the time of de-clamping)
    4. 4 hours +/- 1 hour (after instillation)
    5. 14 hours +/- 1 hour (14 hours after instillation or 12 hours from de-clamping).
    6. 24 hours +/- 1 hour after instillation to ensure complete characterization of cidofovir elimination.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01816646
Sponsor's protocol ID
2012-0903
Other IDs
NCI-2013-02184
Status last verified
Dec 2016
First submitted
20 Mar 2013
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Aitken SL, Zhou J, Ghantoji SS, Kontoyiannis DP, Jones RB, Tam VH, Chemaly RF. Pharmacokinetics and safety of intravesicular cidofovir in allogeneic HSCT recipients. J Antimicrob Chemother. 2016 Mar;71(3):727-30. doi: 10.1093/jac/dkv393. Epub 2015 Nov 26.

    PubMed 26612873

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cidofovir and Probenecid in people with Blood And Marrow Transplantation, run by M.D. Anderson Cancer Center at 1 site in United States.

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: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816646, which also lists 1 linked publication.

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 6 Dec 2016.

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