Brain Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who have recently been diagnosed with glioblastoma (a type of brain cancer), confirmed by a tissue sample, following the 2021 WHO diagnostic guidelines
• People whose tumor tissue has been tested for a specific protein marker called MGMT methylation status, with results available locally
• People whose tumor tissue shows an active form of a protein called STAT3, as confirmed by a central laboratory in Padova, Italy
• People who are able to start combined chemotherapy and radiation therapy within 7 weeks of their brain surgery
• People whose cancer has not shown signs of growth or spread after surgery
• People whose stored tumor tissue (preserved in paraffin wax) is available for testing
• People aged 18 years or older
• People who are in reasonably good general health, as measured by standard performance scales used by doctors (confirm with trial site)
• People who have provided written agreement to take part before any study procedures begin
• People who are willing and able to use adequate contraception throughout the trial and for 6 months after the last dose of the study chemotherapy drug, Temozolomide — this applies to both males and females
• People whose blood tests taken within 10 days before starting the study treatment show that bone marrow, liver, and kidney function meet the following standards:
  • Haemoglobin (red blood cell measure) above 9.0 g/dL
  • A sufficient level of infection-fighting white blood cells, without the need for growth-stimulating medications
  • Platelet count (cells that help blood clot) at or above 100,000 per microlitre
  • Total white blood cell count at or above a minimum level
  • Liver function markers (bilirubin, ALT, AST, and alkaline phosphatase) within acceptable ranges
  • Kidney function markers (creatinine and a calculated kidney filtration rate) within acceptable ranges
  • Blood clotting measures within acceptable ranges (people on anticoagulant medications may still be considered if there is no history of abnormal clotting, confirm with trial site)
  • A normal urine test result
• People whose steroid medication dose has been stable or decreasing in the 10 days before their brain MRI scan

Who may not be able to join:

• People with glioblastoma who only had a small diagnostic biopsy and did not have a more extensive surgical procedure
• People who have already received chemotherapy, immunotherapy, or other cancer treatments for their glioblastoma
• People whose tumor tissue does not show activity of the STAT3 protein
• People who have another cancer diagnosis or cancer that has spread to the brain from elsewhere
• People with serious or poorly controlled health conditions, including uncontrolled high blood pressure, active infection with hepatitis B, hepatitis C, or HIV, or significant problems with bone marrow, organ, or general health function
• People who are unable to follow the study procedures and requirements
• People for whom a brain MRI scan is not medically safe
• People who are pregnant or breastfeeding
• People who are unable to swallow capsules or dissolve sachets in water and drink them
• People who are unable to provide written consent to participate
• People whose glioblastoma has spread to the membranes surrounding the brain and spinal cord
• People with significant heart conditions, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past 6 months, certain heart rhythm problems requiring specific medications, or uncontrolled high blood pressure despite treatment
• People who have had a stroke, mini-stroke, or blood clot in the lungs within the 6 months before starting the study
• People with an active infection of moderate or greater severity
• People with a known history of HIV, or active or ongoing hepatitis B or C requiring antiviral treatment
• People who have received an organ transplant from a donor
• People with any history of abnormal bleeding or clotting disorders, including mild forms, regardless of severity
• People with wounds, ulcers, or bone fractures that have not fully healed
• People who require dialysis due to kidney failure
• People with active interstitial lung disease (a type of lung condition) with ongoing symptoms at the time of enrolment
• People with high levels of protein in their urine, above 3.5 g per 24 hours

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