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The researchers are asking patients with NF2 related tumors to be in the study, because their hearing has decreased and/or their NF2 related tumor has started to grow.
The goals of this study are:
- Determine if selumetinib will stop NF2 related tumors from growing
- Measure the changes in hearing after receiving selumetinib for 6 months.
- Determine if selumetinib improves how participants feel (physically and emotionally) and how participants can perform daily activities.
- Examine tumor tissue, if available, in a laboratory to see if NF2 related tumors have targets of selumetinib.
This is a Phase 2 trial to assess the hearing response rate and radiographic response of VS in children and young adults with NF2 who are treated with selumetinib. Dosing will be based on age: For patients with NF2 who are 3 to < 18 years of age, dosing will be based on BSA. Dosing is based on BSA calculated at the beginning of each course. For patients with NF2 who are ≥ 18 to 45 years of age, dosing will be the standard adult dose of 75 mg BID.
Selumetinib is taken orally twice a day continuously. One course is equivalent to 28 days. Therapy may continue for up to two years (26 courses) in the absence of disease progression or unacceptable toxicity.
There will be two treatment strata. Stratum 1 is for those patients who have a target vestibular schwannoma which is causing hearing loss. Stratum 2 will be reserved for patients who exhibit growth of a tumor(s) besides vestibular schwannoma and are therefore not eligible for stratum 1.
Cincinnati Children's Hospital Medical Center
Not yet recruiting
Children's Hospital Medical Center, Cincinnati
Published on BioPortfolio: 2017-03-30T00:08:22-0400
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A group of disorders characterized by an autosomal dominant pattern of inheritance with high rates of spontaneous mutation and multiple neurofibromas or neurilemmomas. NEUROFIBROMATOSIS 1 (generalized neurofibromatosis) accounts for approximately 95% of cases, although multiple additional subtypes (e.g., NEUROFIBROMATOSIS 2, neurofibromatosis 3, etc.) have been described. (From Neurochirurgie 1998 Nov;44(4):267-72)
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