A Study Exploring New Therapies for Newly Diagnosed Glioblastoma

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Full Title

INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT)

Purpose

Glioblastomas that have an “unmethylated” MGMT gene are less likely to respond to the standard chemotherapy drug temozolomide. In this study, researchers are comparing three investigational treatments (abemaciclib, CC-115, and neratinib) with the standard treatment (temozolomide and radiation therapy) in patients newly diagnosed with glioblastoma.

Patients in this study will receive one of these treatment regimens:

  • Conventional treatment with temozolomide and radiation therapy followed by abemaciclib, a drug used to treat breast cancer which inhibits tumor growth by blocking certain enzymes called CDKs that cancer cells use to grow and divide
  • Radiation therapy plus CC-115 (a drug designed to inhibit the growth of cancer cells by blocking an enzyme cancer cells need called DNA-PK and a protein called mTOR) followed by CC-115 alone
  • Temozolomide and radiation therapy followed by neratinib, a drug that blocks abnormal HER2, a protein some cancer cells use to grow
  • Temozolomide and radiation therapy followed by temozolomide alone

All of the medications used in this study are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed MGMT-unmethylated glioblastoma that has not yet been treated with chemotherapy or radiation therapy. Prior surgery is permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 866-886-9807.

Protocol

19-138

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators