Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
Primary Purpose
Papilloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cidofovir
Sponsored by
About this trial
This is an interventional treatment trial for Papilloma
Eligibility Criteria
Inclusion Criteria: Your child may be eligible for this study if he/she: Has active laryngeal papillomatosis (warts in the throat) that requires 8 or more surgeries per year. Developed this infection before the age of 16. Is between the ages of 2 and 17 years with consent of parent or guardian. Exclusion Criteria: Your child will not be eligible for this study if he/she: Has a history of a prior malignancy (cancer), kidney disease, or immune system deficiency. Is HIV-positive. Is allergic to probenecid. Has received radiation therapy to the throat area or has received certain medications. Is pregnant or breast-feeding.
Sites / Locations
- NIAID/DMID/CASG Central Unit
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001126
First Posted
January 17, 2000
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001126
Brief Title
Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
Official Title
A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see what dose of the drug cidofovir is safe to treat laryngeal papillomatosis (warts in the throat which occur over and over) in children.
Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This study tests the safety of giving this drug to children.
Detailed Description
Your child will be assigned randomly (like tossing a coin) to receive either cidofovir or placebo (an inactive substance). Neither you nor your doctor will know which your child is receiving. Your child will undergo a total of 6 bronchoscopic procedures, which involves placing a tube down your child's throat so that the warts can be seen and treated. The warts will be removed by laser or other procedures and the study drug injected. Study drug will be injected at the sites of all newly removed warts and warts which were removed during earlier study visits. This procedure will be performed every other week. Blood and urine tests will also be performed at this time. Your child will be under general anesthesia during each procedure and will be in the surgery unit for about 6 to 8 hours. Your child will also have to be seen by the doctor 2 days after the procedure. Your child will be followed for a total of 5 years to make sure he/she develops normally and to monitor any side effects of cidofovir. Follow-up visits will take place at Months 3, 6, and then once every 6 months through Year 5. If necessary, laser or other procedures will be performed at these visits to remove any warts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papilloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cidofovir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Your child may be eligible for this study if he/she:
Has active laryngeal papillomatosis (warts in the throat) that requires 8 or more surgeries per year.
Developed this infection before the age of 16.
Is between the ages of 2 and 17 years with consent of parent or guardian.
Exclusion Criteria:
Your child will not be eligible for this study if he/she:
Has a history of a prior malignancy (cancer), kidney disease, or immune system deficiency.
Is HIV-positive.
Is allergic to probenecid.
Has received radiation therapy to the throat area or has received certain medications.
Is pregnant or breast-feeding.
Facility Information:
Facility Name
NIAID/DMID/CASG Central Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
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