About this trial
This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma. Glioblastoma is difficult to treat effectively because the cells within the tumor vary widely and are controlled by factors within and around the tumor, requiring multiple approaches to treat the tumor. The study drug WP1066 targets a specific pathway, known as STAT3, which is responsible for promoting tumor growth and causing the body's immune system to avoid attacking the tumor. Radiation therapy prevents glioblastoma from growing. Giving WP1066 with radiation therapy may prevent glioblastoma from growing and prolong survival.
Eligibility criteria
Qualifiers
Newly diagnosed, histologically confirmed World Health Organization (WHO) glioblastoma multiforme (GBM), IDH wild-type
External pathology reports are permitted for confirmation of histological diagnosis
Documentation of isocitrate dehydrogenase (IDH) wild-type status will be by IDH1 R123H immunohistochemistry, except for patients =< age 54 for whom IDH sequencing will be required to detect noncanonical IDH mutations
Documentation of O6-methylguanine-DNA methyltransferase (MGMT) unmethylated status per testing at any Clinical Laboratory Improvement Amendment (CLIA) certified laboratory
Disqualifiers
Receipt of investigational agents within =< 2 weeks prior to registration
Prior receipt of gene therapy, at any time
Prior receipt of bevacizumab, at any time
Prior receipt of Gliadel, at any time
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Magnetic Resonance Imaging
- Radiation Therapy
- STAT3 Inhibitor WP1066
- Surgical Procedure
Treatment groups
Sponsors and collaborators
Northwestern University
Lead sponsor
Moleculin Biotech, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator