- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00205374
Use of Cidofovir for Recurrent Respiratory Papillomatosis
Use of Cidofovir Injection in the Treatment of Recurrent Respiratory Papillomatosis."
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The focus of the present study is to evaluate the usefulness of cidofovir injection in diminishing the frequency and magnitude of papilloma recurrences in adult and pediatric RRP patients. Briefly, patients will be randomized into either a treatment (cidofovir injection) or a placebo group. The following measures will be made at each of 6 data collection time points, over the course of one year: (1) tumor load, based upon a published staging system for papilloma, (2) degree of respiratory obstruction for phonation, as assessed by phonation threshold pressures, and (3) general health, on validated health inventories (SF12 and Voice Handicap Index for adults; PedsQL (Trademarked) for children) and via measures of height weight and days absent from school or daycare, where applicable, for children. A repeated measures analysis will allow examination of time by treatment interactions to determine if the cidofovir injection group has fewer, or less severe, recurrences than the placebo group.
Specifically, we will answer the following questions in this investigation:
- Does cidofovir injection reduce the frequency of RRP recurrences?
- Does cidofovir injection reduce the magnitude of RRP, as assessed with a proposed staging system for RRP (Derkay et al., 1998) and measures of phonatory threshold pressure?
- Does cidofovir injection improve general health, as assessed by height, weight and days absent from school in pediatric patients and health inventories (general health and voice-related) in children and adults?
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 4 surgeries for RRP in last 12 months
Exclusion Criteria:
- Renal insufficiency
- Nephrotoxic drugs in the last 7 days
- Sulfa allergies
- Currently treated with systemic or topical HPV chemotherapeutic agents
- Females of childbearing potential with a positive pregnancy test
- Women who are breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Cidofovir
Cidofovir (Vistide) is a commercially available agent approved by the FDA for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
The drug is not FDA approved for the treatment of RRP at this time.
However, recent case reports have been encouraging with regard to the effectiveness of the agent in the treatment of RRP.
The FDA has granted this study a "safe to proceed" designation with IND 58,481.
|
With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults.
The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected.
Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis.
Other Names:
|
PLACEBO_COMPARATOR: Placebo
On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group.
A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
|
On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group.
A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Papilloma Severity
Time Frame: Baseline, 2 months, and 12 months
|
Derkay Severity Score. Minimum Score is Zero. Maximum score is 86. Treatment of RRP with cidofovir injection will be considered efficacious if drug group patients experience clinically or statistically significant changes in papilloma severity and inter-surgery time intervals (relative to pre-treatment assessments), when compared with placebo group patients. The scale rates - Voice (normal 0, abnormal 1, aphonic 2) Stridor (absent 0, present with activity 1, present at rest 2) Urgency of the intervention (scheduled 0, elective 1, urgent 2, emergent 3) Respiratory distress (none 0, mild 1, mod 2, severe 3, extreme 4). For multiple anatomical sites (18 or more) in the upper airway, left and right sides, lesions are rated as 0=none, 1=surface lesion, 2=raised lesion, and 3=bulky lesion). A higher rating value indicates more advanced disease and a worse outcome. |
Baseline, 2 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12-month Change in Voice Handicap Index (VHI) Score
Time Frame: 2 months, and 12 months
|
Voice Handicap Index. This scale rates a patient's perception of voice related handicap in the domains of functional, physical, and emotional. There are 10 questions for each domain. Each question is rated by the subject on a 5-point scale, never =0, almost never =1, sometimes =2, almost always =3, always =4). A lower total score or domain score indicates improved, or less, voice handicap. Thus, the maximum total score is 4 X 30 = 120. For each domain, the maximum score is 4 X 10 = 40. Scores of 0 are the lowest possible score. In the paper we say that the Maximum score is 100, but obviously is it actually 120. Complete scale = 0-120. Lower score indicates improved perceived voice-realted quality of life. |
2 months, and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: J. Scott McMurray, MD, University of Wisconsin Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Infections
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- DNA Virus Infections
- Tumor Virus Infections
- Neoplasms, Squamous Cell
- Recurrence
- Respiratory Tract Infections
- Papillomavirus Infections
- Papilloma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Cidofovir
Other Study ID Numbers
- 1999-196
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Respiratory Papillomatosis
-
National Cancer Institute (NCI)CompletedHuman Papilloma Virus | Recurrent Respiratory Papillomatosis | Laryngeal Papilloma, Recurrent | Respiratory PapillomatosisUnited States
-
Queen Sirikit National Institute of Child HealthMerck Sharp & Dohme LLCCompletedHuman Papilloma Virus | Recurrent Laryngeal PapillomatosisThailand
-
Centro de Investigación en. Enfermedades Infecciosas...UnknownRecurrent Respiratory PapillomatosisMexico
-
National Institute of Child Health, HungaryMerck Sharp & Dohme LLCUnknownRecurrent Respiratory PapillomatosisHungary
-
Nventa Biopharmaceuticals CorporationCompletedPapilloma | Recurrent Respiratory PapillomatosisUnited States
-
Imagine InstituteRecruitingJuvenile Recurrent Respiratory PapillomatosisFrance
-
Massachusetts Eye and Ear InfirmaryWithdrawnRecurrent Respiratory Papillomatosis
-
Massachusetts General HospitalCompletedRecurrent Respiratory PapillomatosisUnited States
-
National Cancer Institute (NCI)CompletedHuman Papilloma Virus | Recurrent Respiratory Papillomatosis | Laryngeal Papilloma, Recurrent | Respiratory Papillomatosis | Juvenile Laryngeal PapillomaUnited States
-
Massachusetts Eye and Ear InfirmaryRady Children's Hospital, San DiegoCompletedRecurrent Respiratory PapillomatosisUnited States
Clinical Trials on Cidofovir
-
University of PennsylvaniaCompletedPrevention of Hair GrowthUnited States
-
National Cancer Institute (NCI)Completed
-
Mithra PharmaceuticalsCompletedUterine Cervical Neoplasms | Cervix Intraepithelial NeoplasiaBelgium
-
National Center for Research Resources (NCRR)Northwestern UniversityCompletedAcquired Immunodeficiency Syndrome | Cytomegalovirus Retinitis
-
Medical University of ViennaUniversity of ViennaCompletedAcute Renal Failure | Cytomegalovirus RetinitisAustria
-
M.D. Anderson Cancer CenterActive, not recruitingTransplantation InfectionUnited States
-
ChimerixCompletedCMVUnited States, Belgium, Canada
-
Hospital Universitari Vall d'Hebron Research InstituteUnknown
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI); The Emmes Company, LLCCompletedPrecancerous Condition | Anal CancerUnited States