PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Status:
Recruiting
Trial end date:
2033-11-14
Target enrollment:
Participant gender:
Summary
Background:
About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United
States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people
with malignant tumors in the brain and spinal cord will die within 5 years. Many of these
people have changes in certain genes (MYC or MYCN) that drive the development of their
cancers.
Objective:
To test a study drug (PLX038) in people with tumors of the brain or spinal cord.
Eligibility:
People aged 18 years or older with a tumor of the brain or spinal cord. Some participants
must also have tumors with changes in the MYC or MYCN genes.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have
imaging scans and a test of their heart function. They may need to have a biopsy: A sample of
tissue will be removed from their tumor.
PLX038 is given through a tube attached to a needle inserted into a vein in the arm. All
participants will receive PCX038 on the first day of each 21-day treatment cycle. They will
take a second drug 3 days later to help reduce the risk of infection; for this drug,
participants will be shown how to inject themselves under the skin at home.
Blood tests, imaging scans, and other tests will be repeated during study visits. Hair
samples will also be collected during these visits. Some participants may have an additional
biopsy.
Study treatment will continue up to 7 months.
Follow-up visits will continue every few months for up to 5 years.