Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been newly diagnosed with a specific type of brain tumor called glioblastoma (GBM), confirmed by a tissue sample (biopsy or surgery), with specific genetic features called "IDH wild-type" and "MGMT unmethylated" (confirm with trial site for testing details)
• You are in one of two groups: either you had surgery to remove as much of the tumor as possible (Cohort 1), or you did not have full removal surgery (Cohort 2)
• If you are in Cohort 2, your tumor must be measurable on a brain MRI scan taken within the last 4 weeks, and your medical team must feel you could benefit from further non-emergency surgery
• You are able to start the trial treatment within 8 weeks of your first brain surgery or biopsy that led to your GBM diagnosis
• You are 18 years of age or older
• You are able to carry out most daily activities (your doctor will assess this using a standard scale)
• Your recent blood test results show that your blood cell counts, liver function, kidney function, and blood clotting levels are within acceptable ranges (tests must be done within 30 days before joining)
• You are willing and able to have brain MRI scans with contrast dye
• You agree to use reliable contraception during the trial and for a period after the last dose of the study drug (2 months for women, 4 months for men), and agree not to donate eggs or sperm during this time
• You are able to understand and sign a consent form (or have a legal representative do so on your behalf)
• People of all races, ethnicities, and genders may participate

Who may not be able to join:

• You have received any experimental treatment within the last 2 weeks
• You have ever received gene therapy at any point in the past
• You have ever received a cancer drug called bevacizumab (Avastin)
• You have ever received a chemotherapy wafer called Gliadel placed in the brain
• You are currently using a device called Optune (tumor treating fields) and cannot safely stop using it before starting the trial
• You are currently receiving other cancer treatments and are unable to stop them before starting the trial
• You have had an allergic reaction to a drug that is chemically similar to the study drug WP1066 (confirm with trial site)
• You are HIV-positive and currently on combination antiretroviral therapy, due to potential drug interactions
• You are taking certain medications that significantly interact with a group of liver enzymes called CYP450 and cannot safely stop them at least 2 weeks before starting the trial (confirm with trial site for specific medications)
• You are taking certain other specific medications within 7 days before starting the trial that may interact with the study drug (confirm with trial site for the specific list)
• You are on steroid medications and your dose needs to be increased (those on a stable or reducing dose for at least one week may still be eligible)
• You have a history of bleeding in the brain, unless it was small and caused no symptoms (confirm with trial site)
• You have seizures that are not well controlled, or that require adding or increasing seizure medications
• Your brain tumor is larger than 50 mm across, has caused a significant shift of brain structures toward the midline (more than 5 mm), or has caused a build-up of fluid in the brain
• Your tumor has spread widely across the lining of the brain and spinal cord (called leptomeningeal disease)
• You have a specific heart rhythm measurement (QTc) of 450 ms or more on an ECG (heart tracing)
• You have certain conditions that may make you more sensitive to radiation therapy, such as scleroderma, Sjögren's disease, or certain inherited conditions (confirm with trial site)
• You are pregnant or planning to become pregnant immediately (a pregnancy test will be required within 2 days before starting treatment)
• You are breastfeeding and are unwilling or unable to stop breastfeeding while on the study drug
• You have a serious ongoing infection requiring treatment (other than an uncomplicated urinary tract infection), uncontrolled heart problems, unstable mental health conditions, or any other serious illness that the trial doctor feels could interfere with your safety or the study

Important: Always verify eligibility with the trial site directly before applying.