Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Pr… (NCT04283669) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
United States12 participantsStarted 2020-02-18
Plain-language summary
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.
Who can participate
Age range6 Years
SexALL
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Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
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.
The NIH criteria include presence of:
* Bilateral vestibular schwannomas, OR
* First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR
* Two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity.
The Manchester criteria include presence of:
* Bilateral vestibular schwannomas, OR First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR - Two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity OR
* Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR
* Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR
* Any two of: schwannoma, glioma, neurofibroma, cataract.
Patients must have progressive and measurable disease, defined as at least one VS with the following qualities:
* ≥ 0.75 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced cranial MRI scan with fine cuts through the internal auditory canal (1 mm slices, no skip)
* MRI evidence of pr…