BMX-001 in Newly DX HGG Patients

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 when 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 this Study?

Adults who:

- Have been diagnosed with Grade III or Grade IV Glioma brain cancer

- Are within 12 weeks of the surgery for their brain cancer

- Have not had radiation for any brain cancer

Age Group
Adults
Participating Institutions

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

Contacts
Tisch Brain Tumor Center DCI Clinical Research Team
Protocol Number
IRB:
PRO00062660

NCT:
NCT02655601
ClinicalTrials.gov
View on ClinicalTrials.gov