Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT03095248
Phase
PHASE2
Status
Terminated

Conditions

  • Ependymoma
  • Glioma
  • Meningioma
  • Neurofibromatosis 2
  • Vestibular Schwannoma

Eligibility Criteria

Sex
ALL
Age
3 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Selumetinib — DRUG
    Continuous twice daily dosing; oral agent

Study Details

In this research study the researchers want to learn more about the effects (both good and bad) the study drug selumetinib has on participants with neurofibromatosis type II (NF2) related tumor. 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.

Key Dates

Start date
May 8, 2017
Status verified
Apr 2025
Primary completion
May 21, 2024
Completion
May 21, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1 - NF2 related vestibular schwannomas
    Stratum 1 included patients with NF2 with vestibular schwannomas who exhibit hearing loss. Participants received continuous twice daily dosing of selumetinib. Dosing was based on BSA calculated at the beginning of each course. One course is equivalent to 28 days. Therapy continued for up to two years (26 courses) in the absence of disease progression or unacceptable toxicity.
  • Experimental: Stratum 2: other NF2 related tumors (meningiomas and ependymoma)
    Stratum 2 will include patients who have progressive lesions other than VS (including non-vestibular schwannomas, meningiomas, and spinal cord lesions). Participants will receive continuous twice daily dosing of selumentinib. Dosing is based on BSA calculated at the beginning of each course. 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.

Primary Outcome Measure

Stratum 1- Number of Patients With Hearing Response at 24 Weeks as Measured by Word Recognition [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

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