BMX-MBM-001 (Brain Metastases)

What is the Purpose of this Study?

If you choose to join this study, you will:
- Be randomly assigned (like the flip of a coin) to one of two groups:
-- Group 1 will get the study drug, BMX-001 in an shot under the skin and whole brain radiation therapy. You will get the first shot a couple of days before radiation therapy starts, and twice a week during radiation therapy. The last shot is given about 2 days after radiation therapy is finished.

-- Group 2 will only get whole brain radiation therapy

-- Provide information on your quality of life, side effects of treatment, survival and neurocognitive effects before and after whole brain radiation therapy is given
What is the Condition Being Studied?
Brain Cancer

Who Can Participate in this Study?

Adults who:

- Have primarily been diagnosed with non-small cell lung cancer, breast cancer, melanoma or renal cancer and the cancer has spread to the brain

- Have greater than 10 brain tumors with radiation treatment plan to include whole brain radiation

- Negative pregnancy test for women who could become pregnant

Age Group
Adults
Participating Institutions
Duke University Health System

What is Involved?

We are doing this study is to find out what effects (good or bad) the study drug, BMX-001, may have on memory and thinking when given with whole brain radiation therapy for cancer that has spread to the brain.

Study Details

Full Title
A safety lead-in/randomized phase 2 study of BMX-001 as a therapeutic agent for treatment of cancer patients with multiple brain metastases undergoing whole-brain radiotherapy
Principal Investigator

Contacts
Protocol Number
IRB:
PRO00100377

NCT:
NCT03608020
ClinicalTrials.gov
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