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Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

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ClinicalTrials.gov Identifier: NCT01295645
Recruitment Status : Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if adding cidofovir to the standard of care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to standard of care alone. The safety of cidofovir will also be studied.

Condition or disease Intervention/treatment Phase
Transplantation Infection Drug: Cidofovir Other: No Cidofovir Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of Cidofovir Versus Best Supportive Care for Polyomavirus Hominis Type I (BK) Virus Related Hemorrhagic Cystitis After Stem Cell Transplant
Actual Study Start Date : March 2011
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cidofovir

Arm Intervention/treatment
Experimental: Standard of Care + Cidofovir
Cidofovir 0.5 mg/kg IV 3 x week for 4 weeks
Drug: Cidofovir
0.5 mg/kg by vein (IV) 3 times a week for 4 weeks.
Other Name: Vistide

Active Comparator: No Cidofovir
Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.
Other: No Cidofovir
Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.




Primary Outcome Measures :
  1. Number of Patients with Microbiologic Response [ Time Frame: 8 weeks ]
    Response defined as improvement in symptoms based on questionnaire, reduction or stability in grade of hemorrhagic cystitis, and level of virus must be a 1 log reduction from baseline when the BKV was first diagnosed.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC per NCI criteria) and positive BKV in urine >1x103 DNA copies/ml
  2. Age >/= 6 years
  3. Patient must sign the informed consent document.

Exclusion Criteria:

  1. Creatine clearance < 55 ml/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation
  2. Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
  3. Use of cidofovir for bladder instillation
  4. Use of formalin or hyperbaric oxygen treatment

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): NCT01295645


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
Investigators
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Principal Investigator: Borje S. Andersson, MD,PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01295645     History of Changes
Other Study ID Numbers: 2010-0518
NCI-2011-00250 ( Registry Identifier: NCI CTRP )
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Stem Cell Transplant
Hemorrhagic Cystitis
Bladder inflammation
Frequent urination
Pain
Polyomavirus hominis type I
BK virus
BKV
Cidofovir
Vistide
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases
Cidofovir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action