Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis

NCT00956176 | Withdrawn

• 1 other identifier: 2007-0040
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to learn how the body absorbs and processes 1 dose of cidofovir that is given directly into the bladder, in patients with a viral infection that is causing bleeding from the bladder. The safety of this drug dose and the investigational way it is given (directly into the bladder) will also be studied.

Conditions

Cystitis; Bladder Diseases

Keywords

Cidofovir; Vistide; Adenovirus; BK virus infections; HSCT; Hemorrhagic Cystitis; Foley catheter; Viral infection; Bladder instillation; Intravesical; Transurethral catheter; Transplantation

Outcome Measures

Primary Outcomes (1)

• Systemic Absorption of Cidofovir via bladder instillation

  Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation.

Study Arms (1)

Cidofovir

EXPERIMENTAL

Drug: Cidofovir

Interventions

Cidofovir DRUG

Single dose of 5 mg/kg administered in 100 ml of normal saline solution through a foley catheter to bladder. The catheter will be clamped for 2 hours to keep the drug in bladder.

Also known as: Vistide

Cidofovir

Eligibility Criteria

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

You may qualify if:

• Polyoma BK or adenovirus viruria has been established either by positive urine cytology or by PCR for BK virus or by positive urine and/or blood culture for adenovirus
• The patient has either gross hematuria and/or passes blood clots
• Signed informed consent form
• Hospitalized patients with a Foley catheter
• Women of childbearing potential must agree to use 2 acceptable methods of birth control (e. g., abstinence, IUD, or barrier method), during the study period and one for a period of 2 months afterward. At least one of the methods must be a barrier method. Males must also agree to use acceptable method of birth control (barrier method) during the study period and for 2 months afterward.

You may not qualify if:

• Serum creatinine \>1.5 mg/dl and/or calculated creatinine clearance \< 55 ml/min using the Cockcroft-Gault Creatinine Clearance formula (CrCl). CrCl = {(140-Age) x Weight (kgs) x 0.85 (if female)}/ {72x Serum Creatinine (mg/dl)}
• Urine protein \> 100 mg/dl (equivalent to \> 2+ proteinuria)
• Age less than 18 years
• Prior therapy with formalin or carboprost 1 mg % administered intravesically
• Hypersensitivity to cidofovir, probenecid or sulfa-containing medications
• Have received prior cidofovir therapy within 2 weeks.
• Prior enrollment in the study
• Women who are pregnant or breast-feeding
• Evidence of end-organ adenoviral infection

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gilead Sciences: collaborator

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Cystitis; Urinary Bladder Diseases; Adenoviridae Infections; Cystitis, Hemorrhagic; Virus Diseases

Interventions

Cidofovir

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; DNA Virus Infections; Infections

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roy F. Chemaly, MD, MPH, MBA

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Last Updated: May 14, 2019

Record last verified: 2019-05