Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ependymoma
- Glioma
- Meningioma
- Neurofibromatosis 2
- Vestibular Schwannoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: All participants with neurofibromatosis type 2 (NF2) will be stratified based upon tumor type. Vestibular schwannomas are assigned and analyzed as Stratum 1 and all other NF2 associated tumor types will be analyzed as Stratum 2.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 3 years and 45 years
- Gender
- Both males and females
Description
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 c...
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.
Tracking Information
- NCT #
- NCT03095248
- Collaborators
- AstraZeneca
- Investigators
- Study Chair: Trent Hummel, MD Children's Hospital Medical Center, Cincinnati
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