Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven M. Zeitels, MD, FACS, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01020747
First received: November 13, 2009
Last updated: December 18, 2012
Last verified: December 2012

November 13, 2009
December 18, 2012
November 2009
March 2011   (final data collection date for primary 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Reduction in size and recurrence of papillomatosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01020747 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Respiratory Papillomatosis
  • Drug: Avastin® (bevacizumab)
    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.
    Other Name: Avastin®
  • Drug: Saline
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01020747
VC-P001
No
Steven M. Zeitels, MD, FACS, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Steven M Zeitels, MD Massachusetts General Hospital
Massachusetts General Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP