Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01295645
First received: February 10, 2011
Last updated: June 6, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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: 150
Study Start Date: March 2011
Estimated Primary Completion Date: March 2018 (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.
Drug: Cidofovir
0.5 mg/kg by vein (IV) 3 times a week for 4 weeks.
Other Name: Vistide
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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295645

Contacts
Contact: Borje S. Andersson, MD,PHD 713-792-8750

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Borje S. Andersson, MD,PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01295645     History of Changes
Other Study ID Numbers: 2010-0518, NCI-2011-00250
Study First Received: February 10, 2011
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014