Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis
This study has been withdrawn prior to enrollment.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00956176
First received: August 7, 2009
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cystitis Bladder Diseases |
Drug: Cidofovir |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intravesical Cidofovir Instillation in HSCT Recipients With Hemorrhagic Cystitis: A Single Dose Pharmacokinetic Study |
Resource links provided by NLM:
MedlinePlus related topics:
Bladder Diseases
Drug Information available for:
Cidofovir
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Systemic Absorption of Cidofovir via bladder instillation [ Time Frame: Blood collected pre-instillation, 1 hour, 2 hours, 4 hours and 14 hours after instillation. ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cidofovir |
Drug: Cidofovir
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.
Other Name: Vistide
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00956176 History of Changes |
| Other Study ID Numbers: | 2007-0040 |
| Study First Received: | August 7, 2009 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Cidofovir Vistide Adenovirus BK virus infections HSCT Hemorrhagic Cystitis |
Foley catheter Viral infection Bladder instillation Intravesical Transurethral catheter Transplantation |
Additional relevant MeSH terms:
|
Urinary Bladder Diseases Cystitis Urologic Diseases Cidofovir Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Antiviral Agents Anti-Infective Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on May 16, 2013