MAGIC: MTX110 by CED w/ or w/o Lomustine (Recurrent Glioblastoma)

What is the Purpose of this Study?

We are doing this study to learn if the study drugs MTX110 and Lomustine can be safely and effectively delivered directly to the tumor in adults diagnosed with a recurrence of a glioblastoma.

What is the Condition Being Studied?

Recurrent Glioblastoma

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with a glioblastoma that has recurred
- Are able to have MRI scans
- Do not have a known isocitrate dehydrogenase (IDH) mutation
- Have completed brain tumor radiation treatment at least 12 weeks ago
- Are not pregnant or nursing

For more information about who can be in this study, please contact the study team at 919-684-5301.

Age Group

What is Involved?

If you choose to join this study, you will stay at the hospital for about 2.5 days to have surgery. This surgery will involve:
- Taking a biopsy (small sample) of your brain tumor
- Placing a catheter (small tube) in your brain
- Placing a pump under the skin of your abdomen (belly)

You will get the study drug through this pump, which will then move the study drug into your brain tissue.

You will return to our clinic every 7 days starting after the first time you get the study drug. During these visits, you will:
- Have a physical exam
- Answer questionnaires
- Have an electrocardiogram
- Have blood drugs
- Have the study drug pump refilled and restarted.
- Have an MRI (only at certain visits)

You will continue to receive the study drug until you decide to stop the study or if the study doctor determines that the drug is not helping you.

Study Details

Full Title
MTX110-102 (MAGIC-G1): Phase 1 Open Label Ascending Dose Study to Assess the Feasibility and Safety of Intermittent Infusions of MTX110 Administered by Convection-Enhanced Delivery (CED) in Patients with Recurrent Glioblastoma (rGBM) (MAGIC-G1 Study)
Principal Investigator
Professor of Neurosurgery
Protocol Number
IRB: PRO00110142
NCT: NCT05324501
Phase I
Enrollment Status