Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With 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. Identifier: NCT00956176
Recruitment Status : Withdrawn
First Posted : August 11, 2009
Last Update Posted : September 7, 2012
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 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.

Condition or disease Intervention/treatment Phase
Cystitis Bladder Diseases Drug: Cidofovir Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 2012
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cidofovir

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

Primary Outcome Measures :
  1. Systemic Absorption of Cidofovir via bladder instillation [ Time Frame: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation. ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00956176

Sponsors and Collaborators
M.D. Anderson Cancer Center
Gilead Sciences
Principal Investigator: Roy F. Chemaly, MD, MPH, MBA UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00956176     History of Changes
Other Study ID Numbers: 2007-0040
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

Keywords provided by M.D. Anderson Cancer Center:
BK virus infections
Hemorrhagic Cystitis
Foley catheter
Viral infection
Bladder instillation
Transurethral catheter

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents