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Intravesical Cidofovir for Hemorrhagic Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01816646
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : December 6, 2016
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

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


Condition or disease Intervention/treatment Phase
Blood And Marrow Transplantation Drug: Cidofovir Drug: Probenecid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study
Study Start Date : September 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cidofovir
Patients 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.
Drug: Cidofovir
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.
Other Name: Vistide

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




Primary Outcome Measures :
  1. Systemic Absorption of Cidofovir [ Time Frame: 7 days ]

    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 (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.

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/dL 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816646


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Gilead Sciences
Investigators
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Principal Investigator: Roy F. Chemaly, MD, MPH, MBA M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01816646    
Other Study ID Numbers: 2012-0903
NCI-2013-02184 ( Registry Identifier: NCI CTRP )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Keywords provided by M.D. Anderson Cancer Center:
Blood And Marrow Transplantation
Hemorrhagic Cystitis
Bleeding from bladder
Foley catheter
Probenecid
Cidofovir
Vistide
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases
Cidofovir
Probenecid
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action