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
- 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
- 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.
- Have known sensitivity to bevacizumab
- Have been treated systemically with bevacizumab within 4 months (approximately 6
- 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.