Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

NCT01295645 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2010-0518NCI-2011-00250
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplantation Infection

Keywords

Stem Cell Transplant; Hemorrhagic Cystitis; Bladder inflammation; Frequent urination; Pain; Polyomavirus hominis type I; BK virus; BKV; Cidofovir; Vistide

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Microbiologic Response

  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.

  8 weeks

Study Arms (2)

Standard of Care + Cidofovir

EXPERIMENTAL

Cidofovir 0.5 mg/kg IV 3 x week for 4 weeks

Drug: Cidofovir

No Cidofovir

ACTIVE COMPARATOR

Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.

Other: No Cidofovir

Interventions

Cidofovir DRUG

0.5 mg/kg by vein (IV) 3 times a week for 4 weeks.

Also known as: Vistide

Standard of Care + Cidofovir

No Cidofovir OTHER

Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.

No Cidofovir

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Cystitis, Hemorrhagic; Cystitis; Pain

Interventions

Cidofovir

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Borje S. Andersson, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 14, 2011
• Study Start: March 17, 2011
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)