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Monoclonal Antibodies
Bevacizumab for Respiratory Warts
Phase 2
Recruiting
Led By Scott M Norberg, D.O.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial will study if a drug can reduce the number of surgeries needed for people with RRP.
Who is the study for?
Adults over 18 with recurrent respiratory papillomatosis (RRP) needing frequent surgeries for airway growth removal. Must have had at least two surgeries in the past year, be willing to sign consent and undergo biopsies, have good organ function and performance status, not received certain treatments recently, and agree to contraception if applicable.
What is being tested?
The trial is testing Bevacizumab's effectiveness in reducing surgery frequency for RRP patients. Participants will receive the drug intravenously post-surgery every three weeks initially then every six weeks, accompanied by evaluations including endoscopy and heart function tests.
What are the potential side effects?
Bevacizumab can cause bleeding issues, high blood pressure, wound healing complications, gastrointestinal perforations or fistulas. It may also lead to increased risk of stroke or heart problems among other potential side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab.
Secondary study objectives
Rate of pulmonary RRP partial response (PR) and complete response (CR) by RECIST 1.1 in participants with pulmonary disease.
Recurrence free interval after treatment
The rate of papilloma regrowth by determining the percentage of participants with an increase in their surgery-free interval after treatment with systemic bevacizumab
+1 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
pneumonia
4%
cranial nerve VI palsy
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Bevacizumab treatment course
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,935 Total Patients Enrolled
Scott M Norberg, D.O.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
2,320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1, and your ailment is restricted to pulmonary RRP (Respiratory Related Papillomatosis).I have not coughed up more than a teaspoon of bright red blood in the last month.I haven't had a serious heart issue or stroke in the last 6 months.I have not had a gut perforation or abnormal connection in my belly in the last 6 months.My blood pressure is not well controlled, even with medication.I do not have a bleeding disorder or significant blood clotting issues.I've had 2 or more surgeries in the last year for laryngeal or tracheal RRP.I am 18 years old or older.My kidney function, measured by creatinine clearance, is normal or above.I have not had major surgery in the last 4 weeks.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.I have a Derkay score of 8 or more, measurable disease, a tracheostomy, or I am mostly self-sufficient.I do not have any health issues that would stop me from following the study's requirements.My condition is confirmed as RRP through tissue examination.I need surgery to remove my papilloma as per my doctor's advice.My condition is confirmed as RRP through tissue examination.I have a wound that won't heal, an active ulcer, or an untreated broken bone.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have lasting side effects from previous treatments, but not severe hair loss or mild nerve damage.I am willing to have a biopsy for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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