Symptoms and General Pathology

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Rare Diseases

Recurrence

Communicable Diseases

Respiratory Tract Infections

Papillomavirus Infections

Papilloma

Disease Attributes

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Recurrent Respiratory Papillomatosis

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Angiogenesis Inhibitors

Antineoplastic Agents, Immunological

Growth Inhibitors

Bevacizumab injections (\~7.5-12.5mg in 0.3 - 0.5 c.c.) into diseased vocal folds in conjunction with 532 nm pulsed-KTP laser photoangiolysis, administered every 6 ±1 weeks, for a total of 5 treatments. No patient will have an injection volume exceed 0.5 cc. for any single treatment. If initial results indicate a benefit, as described below, an extension of the active treatment period will be permitted up to a total treatment duration of 18 months.

Avastin® (bevacizumab)

A sham injection with saline (0.3-0.5 cc) has been 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.

Saline

Steven M Zeitels, MD

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.

Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)

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

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.

Massachusetts General Hospital

Director: Center for Laryngeal Surgery and Voice Rehabilitation

Subjects received Avastin in the more diseased vocal fold and saline in the other.

Group Avastin

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Monica Tettamanti

Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.

Bevacizumab Treated Vocal Fold

Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.

Untreated Vocal Fold

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.

Overall Study

Spots Global Cancer Trial Database for avastin® (bevacizumab)