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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Radiation Therapy
RadiationUndergo routine radiation therapy
STAT3 Inhibitor WP1066
DrugGiven PO
Surgical Procedure
Procedure/SurgeryUndergo removal or biopsy of tumor
Treatment groups
39 Participants
are divided into 2 treatment groupsGroup A: Cohort I (WP1066, radiation)Experimental treatment 4 interventions
Group B: Cohort II (WP1066, radiation, surgery)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) (Cohort 1)
For PFS analysis, disease progression is defined as progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria Will be summarized using the Kaplan-Meier method.
Time frame
From subject registration to the earlier of the day of first documented disease progression or death from any cause, assessed up to 36 months post-registration2
Tumor microenvironment activation and cluster interactions (Cohort 2)
Time frame
Up to 36 months post-registrationSecondary outcomes
1
Overall Survival (OS)
Will be analyzed using similar methods to PFS.
Time frame
From the date of initial diagnosis until death from any cause, assessed up to 36 months2
Overall Response Rate (ORR)
Defined as the proportion of treated subjects who experience a complete response (CR) or partial response (PR) per RANO criteria.
Time frame
Up to 36 months post-registration3
Duration of response (DOR)
All eligible, registered subjects who have measurable disease at baseline, who have received at least 1 dose of trial therapy, and who experience a CR, PR, or SD per RANO criteria will be evaluable.
Time frame
Up to 36 months post-registration4
Frequency of adverse events
According to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Up to 36 months post-registrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
Moleculin Biotech, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov