WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

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

39 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Northwestern University

Lead sponsor

Moleculin Biotech, Inc.

Collaborator

National Cancer Institute (NCI)

Collaborator