Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

Sponsor: Patrick Wen, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02977780

Provider View

This clinical trial is exploring several new drugs to see if they can help treat Glioblastoma, a type of brain cancer. The study includes drugs like Abemaciclib, Temozolomide, Neratinib, CC115, and QBS10072S.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of several new drugs for treating Glioblastoma, a type of brain cancer. The study will compare the effects of these new drugs with the standard treatment to see if they can help people with Glioblastoma, especially those with specific genetic changes. While Temozolomide is already approved for this cancer, the other drugs are still being studied and are not yet approved for any diseases.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of new drugs to see if they work for treating Glioblastoma. The study will compare the standard treatment with new drugs like Abemaciclib, Neratinib, CC115, and QBS10072S to see if they can help people with Glioblastoma, especially those with specific genetic changes. Temozolomide is already approved for this cancer, but the other drugs are still being studied and are not yet approved for any diseases.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Glioblastoma or gliosarcoma after surgery.
  • No previous chemotherapy or radiation therapy.
  • Age 18 or older.
  • Must be in good general health with a performance status score of 60 or higher.
  • Must have normal blood and organ function based on specific tests.
  • Must be able to swallow pills.
  • Must start radiation therapy 14-42 days after surgery.
  • Tumor must not have a specific mutation (IDH1 R132H) and must have an unmethylated MGMT promoter.
  • Must have genetic testing data available to assign treatment groups.
  • Must be able to undergo MRI scans.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Original diagnosis was a lower grade glioma that later changed to Glioblastoma.
  • Planned major surgery.
  • Currently receiving other experimental treatments.
  • Previous brain radiation therapy.
  • Planned use of Optune™ device.
  • History of another cancer unless it has been treated and is not expected to return.
  • History of significant brain bleeding.
  • Serious heart conditions or diseases.
  • Uncontrolled diabetes or high blood pressure.
  • Active infections or other serious illnesses.
  • Known active Hepatitis B or C.
  • Pregnant or breastfeeding.
  • Gastrointestinal issues that affect drug absorption.
  • Allergic reactions to similar drugs.
  • Taking certain anti-seizure medications or drugs that affect liver enzymes.
  • Using herbal supplements or certain blood thinners.

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