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BMX-001 in Newly DX HGG Patients - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test the effect (good or bad) of the study drug (BMX-001) in given with radiation therapy and temozolomide.

We also want to look at the effect (good or bad) of BMX-001 in how it protects your brain from the worsening of cognitive (thinking) abilities and quality of life that is sometimes experienced when undergoing treatment with radiation therapy and temozolomide for high grade glioma.

What is the Condition Being Studied?

Newly diagnosed High Grade Glioma Brain Cancer (Grade III or Grade IV)

Who Can Participate in the Study?

Adults who:
- Have been diagnosed with Grade III or Grade IV Glioma brain cancer
- Are within 12 weeks of the surgery they had for their brain cancer
- Have had no prior radiation for any brain cancer

Age Group
Adults

What is Involved?

This study is now in the phase II portion of the study. If you join the study, you will:
- Be randomized (Like a flip of a coin) to get either:
-- Arm A: The study drug BMX-001 injected under the skin with standard of care treatment (six weeks of daily radiation therapy and oral chemotherapy [temozolomide])
---The first dose of BMX-001 is given a couple of days before radiation therapy starts, and then you will get 2 injections a week for 8 weeks.

OR

-- Arm B: Standard of care treatment (six weeks of daily radiation therapy and oral chemotherapy [temozolomide])

- Give information on your quality of life, side effects of the treatment, survival and neurocognitive (your ability to think) effects before and after temozolomide and radiation therapy is given.

Study Details

Full Title
A Phase 1/2 Trial for Patients with Newly Diagnosed High Grade Glioma Treated with Concurrent Radiation Therapy, Temozolomide, and BMX-001 (BioMimetix study # BMX-HGG-001)
Principal Investigator
Protocol Number
IRB:PRO00062660
NCT:NCT02655601
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698