Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)

This is an interventional treatment trial for Recurrent Respiratory Papillomatosis Read More

Inclusion Criteria:

• Male or female patients with dysphonia that have been diagnosed with Recurrent Respiratory Papillomatosis (RRP) of the vocal folds
• Age between 18 and 60 years old
• Female patients must be surgically sterilized, postmenopausal, or employ adequate contraception. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 years with absence of menses for greater than 12 months and an elevated serum Hormone, follicle-stimulating (FSH) (> 25 mIU/mL). Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization.
• Have bilateral glottal papillomatosis (i.e., involving both the right and left vocal folds)
• Willing and able to comply with the investigational nature of the study and able to communicate well with investigators.
• Ability to comprehend and willingness to provide written informed consent in accordance with institutional and regulatory guidelines.

Exclusion Criteria:

• Have known sensitivity to bevacizumab
• Have been treated systemically with bevacizumab within 4 months (approximately 6 half-lives).
• Have hematocrits < 30, elevated PT or PTT levels more than 1.2 X the upper limit of normal (ULN) or absolute platelet counts below the lower limit of normal (LLN).
• Have absolute neutrophil counts below 1500
• Have urine dipsticks positive for ≥3+ proteinuria will have spot urine collections and those patients with urine protein to urine creatinine ratios greater than 1.5.
• Have a history of congestive heart failure, angina that remains symptomatic despite medications, myocardial infarction or coronary artery disease-related procedure within the past 6 months (including angioplasty, stent placement, bypass graft surgery) or who have prosthetic heart valves.
• Have significant uncontrolled hypertension (systolic blood pressure above 160 and/or diastolic blood pressure above 100).
• Have had surgeries within 1 month of enrollment or who have un-healed surgical incisions at screening.
• Have a history of thromboembolic events, gastro-intestinal (GI) ulcer or bleeding, or with a history of wound dehiscence.
• Female patients that are pregnant, nursing or plan to nurse during the up to 18 months of treatment period.
• Patients with a history of bleeding disorders, documented platelet dysfunction, current use of anti-platelet drugs, or abnormal prothrombin time (PT) or activated partial thromboplastin timea (PTT) laboratory values as defined in number 3 above.