At a glance
ClinicalIndex Comparison Record- ✓At least 4 surgeries for RRP within the last 12 months
- ✕Renal insufficiency
- ✕Nephrotoxic drugs used in the last 7 days
- ✕Sulfa allergies
- ✕Currently treated with systemic or topical HPV chemotherapeutic agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of Cidofovir Injection in the Treatment of Recurrent Respiratory Papillomatosis."
In Brief
A Phase 4 clinical trial evaluating Cidofovir and Placebo for Recurrent Respiratory Papillomatosis. Completed, enrolled 19 participants.
Detailed Summary
Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence.
Study Details
Timeline
Interventions
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.
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.