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Tyrosine Kinase Inhibitor
Crizotinib for Acoustic Neuroma (NF110 Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lansky/Karnofsky performance status ≥ 60
Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights
NF110 Trial Summary
This trial will test a new drug, crizotinib, on people with Neurofibromatosis Type 2 who have a progressive vestibular schwannoma. The drug will be taken orally, continuously, for 28 days at a time, for up to 12 cycles.
Who is the study for?
This trial is for children and adults over 6 years old with Neurofibromatosis Type 2 (NF2) and growing vestibular schwannomas. Participants must have stable neurologic symptoms, meet specific health criteria, not be on certain drugs or treatments that could interfere, and women of childbearing age must use effective birth control.Check my eligibility
What is being tested?
The trial tests Crizotinib, an oral medication given in continuous 28-day cycles up to a maximum of 12 cycles. It aims to see if it can stop the growth of tumors in patients with NF2 until either the disease progresses further or side effects become too severe.See study design
What are the potential side effects?
Possible side effects include issues from drug interactions due to Crizotinib's effect on liver enzymes, gastrointestinal problems affecting how well the body absorbs the drug, heart rhythm changes, and general risks associated with taking anticancer medications.
NF110 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
Select...
I have been diagnosed with neurofibromatosis 2 according to NIH, Manchester criteria, or a genetic test.
Select...
My organ and bone marrow functions are within normal ranges.
Select...
I have a growing tumor on my hearing nerve that can be measured.
NF110 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Volumetric Response Rate
Side effects data
From 2020 Phase 3 trial • 207 Patients • NCT0163900155%
White blood cell count decreased
50%
Nausea
49%
Anaemia
46%
Vomiting
45%
Alanine aminotransferase increased
37%
Neutropenia
35%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
Decreased appetite
27%
Constipation
27%
Platelet count decreased
24%
Cough
21%
Haemoglobin decreased
20%
Leukopenia
17%
Chest pain
17%
Fatigue
16%
Blood albumin decreased
16%
Hyponatraemia
15%
Pyrexia
13%
Back pain
11%
Dizziness
11%
Dyspnoea
11%
Alopecia
10%
Thrombocytopenia
10%
Asthenia
9%
Diarrhoea
9%
Headache
9%
Insomnia
9%
Red blood cell count decreased
8%
Phlebitis
8%
Visual impairment
8%
Upper respiratory tract infection
8%
Nasopharyngitis
8%
Hypoalbuminaemia
8%
Haemoptysis
8%
Pruritus
7%
Rash
7%
Hypokalaemia
6%
Lymphocyte count decreased
6%
Blood bilirubin increased
6%
Pain in extremity
6%
Abdominal distension
6%
Pain
6%
Productive cough
5%
Oedema peripheral
5%
Musculoskeletal pain
4%
Arthralgia
4%
Vision blurred
4%
Chest discomfort
4%
Blood alkaline phosphatase increased
4%
Gamma-glutamyltransferase increased
4%
Paraesthesia
4%
Hypocalcaemia
3%
Abdominal pain
3%
Protein total decreased
2%
Abdominal pain upper
2%
Hypoaesthesia
1%
Pleural effusion
1%
Disease progression
1%
Death
1%
Blood creatinine increased
1%
Pneumonia
1%
Oedema
1%
Blood lactate dehydrogenase increased
1%
Hypoproteinaemia
1%
Hypertension
1%
Pericardial effusion
1%
Syncope
1%
Transaminases increased
1%
Cerebral infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy
Crizotinib
NF110 Trial Design
1Treatment groups
Experimental Treatment
Group I: Open Label Continuous TreatmentExperimental Treatment1 Intervention
Subjects with Neurofibromatosis Type 2 (NF2) and progressive vestibular schwannoma (VS) will be treated with crizotinib administered orally. Crizotinib will be taken continuously until disease progression or unacceptable toxicity, in continuous treatment cycles of 28 days each, for a maximum of 12 cycles. Clinical response will be assessed by MRI (volumetrics, primary objective) and audiology at the end of every 3rd cycle. Subjects with volumetric tumor progression will be taken off protocol. Patients who complete 12 cycles of treatment without disease progression, but within the following 24 weeks show subsequent disease progression (defined as >20% increase in target tumor volume compared to off-treatment volume), will be eligible for re-treatment on study for up to 48 additional weeks, provided they still meet study eligibility criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizotinib
2014
Completed Phase 3
~2370
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterOTHER
1,937 Previous Clinical Trials
588,301 Total Patients Enrolled
1 Trials studying Neurofibromatosis
50 Patients Enrolled for Neurofibromatosis
University of Alabama at BirminghamLead Sponsor
1,591 Previous Clinical Trials
2,281,646 Total Patients Enrolled
1 Trials studying Neurofibromatosis
45 Patients Enrolled for Neurofibromatosis
Bruce R Korf, MD, PhDStudy DirectorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that is sensitive to changes in my body's enzyme levels.I haven't had radiation on the tumor I want to study in the last year or any radiation in the last 4 weeks.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I am a man and will not use contraception during the study and for 3 months after.I can care for myself but may need occasional help.It's been long enough since my last monoclonal antibody treatment to join.My neurological symptoms have been stable for at least a week.I have a stomach or intestine condition that affects how my body absorbs medication.I have been diagnosed with neurofibromatosis 2 according to NIH, Manchester criteria, or a genetic test.You are expected to live for more than 1 year.My organ and bone marrow functions are within normal ranges.I am not using any strong CYP3A4 inhibitor medications or foods.My cancer is quickly getting worse and I need steroids for brain or spine tumor symptoms.I do not have serious heart rhythm problems or uncontrolled atrial fibrillation.I am 6 years old or older.I have no lingering side effects from previous cancer treatments.I am willing and able to follow the study's requirements.I am not taking any strong medications that affect liver enzymes.I haven't taken cancer drugs in the last 4 weeks.I have a growing tumor on my hearing nerve that can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label Continuous Treatment
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently open to new participants?
"The trial listed on clinicaltrials.gov is no longer in need of participants, with its initial postdate being February 18th 2020 and the most recent update occurring on January 10th 2022. Despite this study's closure for recruitment purposes, 105 other studies are still actively seeking candidates."
Answered by AI
How widely distributed is the trial's presence within this state?
"This research trial is enrolling patients in 17 different locations, including Cincinnati Children's Hospital Medical Center (Site 800) in Ohio, Children's National Medical Center (Site 775) located in Washington D.C., and The University of Alabama at Birmingham (Site 700)."
Answered by AI
Does this treatment pose any risks to the health and safety of patients?
"With prior data confirming safety, we rate the treatment a 2 on our 1-3 scale. This is because this Phase 2 trial has some evidence supporting its security but none regarding effectiveness."
Answered by AI
Is this trial the original of its genre?
"32 active trials for this medication span across 36 nations and 1204 cities. Back in 2011, Pfizer launched a Phase 1 trial with 44 participants which was successful upon completion. Since then, an additional 44 studies have been finished."
Answered by AI
Are there any precedents for this therapeutic approach?
"At present, 32 clinical trials researching this treatment are ongoing. Of those experiments, 6 have progressed to Phase 3 of the trial process. Although the majority of studies for this therapy are located in Westerville, Ohio, there is a total of 6908 sites conducting research linked to it."
Answered by AI
How many participants are registering for this experiment?
"Unfortunately, this medical trial is not currently accepting participants. It was first posted on February 18th 2020 and last updated January 10th 2022. However, there are numerous other studies actively enrolling people with neurofibromatosis 2 (73) or seeking to administer the same treatment (32)."
Answered by AI
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