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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

Phase 1
18 Years
60 Years
Not Enrolling
Recurrent Respiratory Papillomatosis

Thank you

Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Steven M Zeitels, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

March 2011

Related Keywords:

  • Recurrent Respiratory Papillomatosis
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections



Massachusetts General Hospital Boston, Massachusetts  02114-2617