CLINCAL TRIAL STUDYING TREATMENT OF RECURRENT RESPIRATORY PAPILLOMATOSIS (RRP) WITH AVASTIN AND THE PULSED-KTP LASER
The Center for Laryngeal Surgery and Voice Rehabilitation at Massachusetts General Hospital is conducting a study of a drug called Avastin (bevacizumab) for treatment of recurrent respiratory papillomatosis (RRP). In the study, Avastin will be given as an injection on one side only during the usual treatment with KTP laser surgery on both vocal folds. The study will test whether this drug helps reduce symptoms and/or eliminate the return of the disease.
The study involves 5 treatments of Avastin (bevacizumab) with KTP laser. Each treatment is spaced about 6 weeks apart. Follow up appointments will be scheduled approximately 4 months after the last treatment. Total participation commitment in the initial phase is approximately 1 year. Eligible patients will have the option to continue in the study for an additional year of similar treatments. Patients in the extended treatment group will have a last follow up at 4 months after the last treatment or up to a total of 22 months.
If you would like to enroll in the study and you meet the criteria outlined below, please contact Gerardo Lopez-Guerra, M.D. (Research Fellow), at 617-726-0210 or email voice.center@mgh.harvard.edu .
Each patient must meet the following criteria to be enrolled in this study.
1. Male or female patients with dysphonia that have been diagnosed with RRP of the vocal folds
2. Age between 18 and 60 years old
3. 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 FSH (> 25 mIU/mL). Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization.
4. Have bilateral glottal papillomatosis (i.e., involving both the right and left vocal folds)
5. Willing and able to comply with the investigational nature of the study and able to communicate well with investigators.
6. Ability to comprehend and willingness to provide written informed consent in accordance with institutional and regulatory guidelines.
Patients who meet any of the following criteria will be excluded from the study.
1. Have known sensitivity to bevacizumab
2. Have been treated systemically with bevacizumab within 4 months (approximately 6 half-lives).
3. 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).
4. Have absolute neutrophil counts below 1500/ml
5. Patients with urine dipsticks positive for ³3+ proteinuria will have spot urine collections and those patients with urine protein to urine creatinine ratios greater than 1.5.
6. Patients with 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.
7. Patients with significant uncontrolled hypertension (systolic blood pressure above 160 and/or diastolic blood pressure above 100).
8. Have surgeries within 1 month or have un-healed surgical incision at screening.
9. Patients with a history of thromoembolic events, GI ulcer or bleeding, or with a history of wound dehiscence.
10. Female patients that are nursing or plan to nurse during the up to 18 months of treatment period.