Share on facebook Share on Twitter Share on Google Plus Share This
Back to Results

A Study Looking at Targeted Therapy According to Tumor Markers for People With Meningiomas


Title Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations
Therapeutic Area Brain Tumors
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender Both
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT02523014

Overview

The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.

The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK2256098, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.

Study Details

Inclusion Criteria

  • Diagnosis of meningioma with either SMO or NF2 mutations
  • Visible tumor on MRI or CT
  • Otherwise normal organ function

Exclusion Criteria

  • No meningioma outside of the brain
  • No pregnant or nursing women
  • No complicating or uncontrolled diseases including, but not limited to, prior allergic reaction to either study drug or similar drugs, uncontrolled diabetes, or uncontrolled hypertension.

Study Requirements

Subjects will come to clinic for the following screening tests: physical and neurological exam, MRI of brain, blood and urine tests, and a short questionnaire about how tired subjects are and their quality of life. In addition to these tests, subjects’ tissue left-over from a prior surgery will be sent for genetic testing. If subjects have an SMO mutation, they will receive vismodegib, which is a pill that can be swallowed, once a day. If subjects have an NF2 mutation, they will receive GSK2256098, which is a pill that can be swallowed, twice a day. Subjects will continue to receive study drug until their meningioma progresses or if they have an unacceptable side effect to the study drug. Subjects will be asked to keep track of when they take the study drug on a pill diary. While taking the study drug, subjects will come to clinic for physical and neurological exams and for blood and urine tests once a month. Subjects will also have an MRI every 2 months for the first year and then every 3 months thereafter. If subjects agree, extra blood will be drawn for optional research tests. At screening, about 2 tablespoons of extra blood will be drawn for research. While taking study drug, about 1.5 tablespoons of extra blood will be drawn for research every 4 months.