Clinical Trial: Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study to Evaluate the Effects of Antiangiogenic Factor as an Adjunct Treatment After Photoangiolysis in Patients With Bilateral Recurrent Respiratory Papillomatosis

Brief Summary: This phase I single center open labeled study is planned to assess the safety and tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected into the vocal folds. Patients who enroll in the protocol will be injected with bevacizumab in one vocal fold that represents the more diseased of the two folds. A sham injection with saline will be administered to the other vocal fold as the control. This therapy will be administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the initial treatment always getting the drug injection. The investigator will also treat lesions by laser photoangiolysis of both vocal folds using the 532 nm potassium-titanyl-phosphate (KTP) laser.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period. [ Time Frame: 6 months ]

Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.


Original Primary Outcome: Reduction in size and recurrence of papillomatosis [ Time Frame: 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: November 13, 2009
Date Started: November 2009
Date Completion:
Last Updated: December 18, 2012
Last Verified: December 2012