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November 1st 2017

New Clinical Trial for Patients with Newly Diagnosed Glioblastoma (GBM)

New Clinical Trial for Patients with Newly Diagnosed Glioblastoma (GBM)

This study will determine whether the addition of the novel drug ABT-414 improves survival for patients diagnosed with glioblastoma.

 

Dr. Lia Halasz, one of our expert radiation oncologists for brain and central nervous system tumors, is the site principal investigator of RTOG 3508/AbbVie M13-813 that recently opened at the University of Washington. Glioblastoma (GBM) is an aggressive cancer of the brain that is not currently curable with standard therapy. Thus, novel therapies are required to improve patient outcomes. In this trial, patients with newly diagnosed GBM will be randomly (by chance) assigned to receive the experimental drug  ABT-414 in addition to the standard treatment for GBM (radiation therapy combined with the drug Temozolomide) or standard treatment.

 

ABT-414 is a type of drug called an antibody drug conjugate or ADC.  ADCs usually have 2 parts:  a part that targets tumor cells (the antibody) and a cell-killing part (the toxin).  Antibodies are proteins that are part of your immune system.  They can stick to and attack specific targets on cells.  The antibody part of ABT-414 sticks to a target called Epidermal Growth Factor Receptor (EGFR).  EGFR is an important molecule on many normal cells of the body, but in about 40% of people with GBM, there is an excess of EGFR genes, called EGFR amplification, in the tumor, which causes increased amounts of EGFR molecules on the surface of the tumor cells. The cell killing part of ABT-414 is a toxin called monomethyl auristatin F (MMAF).  Once the antibody part of ABT-414 sticks to EGFR on the tumor cells, the ADC goes inside the cell, and the MMAF is released and kills the cell.  Because ABT-414 does not stick to cells with normal amounts of EGFR molecules, ABT-414 does not appear to work in people whose tumors are not EGFR-amplified.

 

Laboratory studies have shown that ABT-414 can kill some tumor cells in a dish and shrink tumors in animals.  Human studies have shown ABT-414 can shrink EGFR-amplified GBMs in some people whose tumors were growing despite earlier RT and TMZ treatment.  However, we do not know if ABT-414 will work in people with GBMs who haven’t already received RT and TMZ.  ABT-414 is not yet approved for use in the United States or any other countries. Abbivie, the company that makes ABT-14, provides the drug and sponsors the trial.

 

Inclusion Criteria:

  • Diagnosis of GBM.
  • EGFR amplification in tumor tissue from surgery (this is tested as part of the study).
  • Good functional status (Karnofsky Performance Status (KPS) 70 – 100).
  • Recovered from the effects of surgery, postoperative infection and other complications of surgery.
  • Adequate bone marrow, kidney, and liver function.

Exclusion Criteria:

  • Multifocal, recurrent or metastatic GBM or gliomatosis cerebri
  • Prior chemotherapy or radiosensitizer for head and neck cancer.
  • Prior radiotherapy to the head or neck which would overlap radiation fields.
  • Prior therapy for GBM or other invasive malignancy.
  • Prior, current or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity antineoplastic therapy.

To learn more about Dr. Halasz’s clinical care and research, please click here or contact Mimi Lee of the clinical trial research team (leemm@uw.edu) to learn more about this clinical trial.

To schedule an appointment with Dr. Halasz, please click here or contact the Alvord Brain Tumor Center at the University of Washington/UW Medicine.

 

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