Trial record 2 of 2 for:    "Laryngeal papillomatosis"

Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001126
First received: January 17, 2000
Last updated: August 26, 2010
Last verified: November 2005
  Purpose

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.


Condition Intervention Phase
Papilloma
Drug: Cidofovir
Phase 1

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 36
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001126

Locations
United States, Alabama
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00001126     History of Changes
Other Study ID Numbers: DMID 97-023
Study First Received: January 17, 2000
Last Updated: August 26, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Papilloma
Laryngeal Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Cidofovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014