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Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295645
First Posted: February 14, 2011
Last Update Posted: May 22, 2017
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.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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 Intervention Phase
Transplantation Infection Drug: Cidofovir Other: No Cidofovir Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Actual Study Start Date: March 2011
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Borje S. Andersson, MD,PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
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 Submitted: February 10, 2011
First Posted: February 14, 2011
Last Update Posted: May 22, 2017
Last Verified: May 2017

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:
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Cidofovir
Antiviral Agents
Anti-Infective Agents