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Crizotinib for Acoustic Neuroma (NF110 Trial)
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.
NF110 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNF110 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 207 Patients • NCT01639001NF110 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Open Label Continuous Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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)."
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."
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."
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."
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)."
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