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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

Tracking Information
First Submitted Date  ICMJE February 10, 2011
First Posted Date  ICMJE February 14, 2011
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE March 2011
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01295645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Official Title  ICMJE 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
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.
Detailed Description

The Study Drug:

Cidofovir is an anti-viral drug that is designed to treat or prevent infections caused by certain kinds of viruses.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups and you will have an equal chance of being in either group:

  • If you are in Group 1, you will receive standard of care drugs and cidofovir. The doctor will tell you more about the standard of care drugs that you will take and the risks for them.
  • If you are in Group 2, you will only receive standard of care drugs.

Study Drug Administration:

If you are in Group 1, you will receive cidofovir by vein over about 1 hour 3 times per week. You will also receive standard of care, which may include oral pain drugs taken every 4 to 6 hours as needed, oral drugs for urinary urgency taken 2 times daily, and fluids given by vein to increase your urination rate.

If you are in Group 2, you will only receive the standard of care, as described above.

Study Visits:

Each week:

  • Blood (about 2 tablespoons) will be drawn for routine tests.
  • You will have a physical exam, including measurement of your vital signs.

Every 2 weeks, you will complete the questionnaire about urinary problems.

Length of Study:

If you are in Group 1, you may continue taking the study drug for up to 4 weeks. Group 2 will take the standard of care for 4 weeks. If the doctor thinks it is needed Groups 1 and 2 can continue to receive standard of care after this study is over. If your symptoms get worse during the study and you are not receiving cidofovir, you may be eligible for further treatments, which may include cidofovir, after the study ends. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-treatment visit and the follow-up visit.

End-of-Treatment Visit:

After you finish treatment:

  • Urine will be collected to test the level of BK virus.
  • You will complete the questionnaire about urinary problems.

Follow-up Visit:

Four (4) weeks after treatment ends:

  • You will have a physical exam, including measurement of your vital signs.
  • Urine will be collected to test the level of BK virus.

This is an investigational study. Cidofovir is FDA approved and commercially available for the treatment of several viral infections. Its use in patients with the BK virus after a stem cell transplant is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transplantation Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Standard of Care + Cidofovir
    Cidofovir 0.5 mg/kg IV 3 x week for 4 weeks
    Intervention: Drug: Cidofovir
  • Active Comparator: No Cidofovir
    Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.
    Intervention: Other: No Cidofovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2011)
150
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01295645
Other Study ID Numbers  ICMJE 2010-0518
NCI-2011-00250 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Borje S. Andersson, MD,PHD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP