A Multi-Arm, Open Label, Phase II Trial of WP1066 and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
Northwestern University
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) outcomes of patients with MGMT-unmethylated glioblastoma treated with STAT3 Inhibitor WP1066 (WP1066) in combination with standard-of-care radiation therapy. (Cohort 1) II. To ascertain the changes induced in the tumor microenvironment by the combination of WP1066 and radiation. (Cohort 2) SECONDARY OBJECTIVES: I. Determine the overall survival (OS) outcomes of patients with malignant gliomas. (Cohort 1 and 2) II. Assess overall response rate (ORR) and duration of response in patients with malignant gliomas using Respon…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 (…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationRadiation Therapy
Undergo routine radiation therapy
- DrugSTAT3 Inhibitor WP1066
Given PO
- ProcedureSurgical Procedure
Undergo removal or biopsy of tumor
Locations (2)
- Northwestern UniversityChicago, Illinois
- Northwestern Medicine: WarrenvilleWarrenville, Illinois