Phase 1 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:

• Adults aged 18 or older.
• People who have been diagnosed with a type of brain tumor called glioblastoma (GBM), confirmed by a lab test using the most current brain tumor classification system.
• People whose brain tumor has clearly come back or grown, as shown on a specific type of brain scan (MRI) using standard measurement guidelines.
• People whose returning tumor is located in the main, upper part of the brain.
• People who have already had surgery and completed a full course of radiation therapy as their first treatment, either alone or combined with chemotherapy (such as temozolomide), and who finished that treatment at least 12 weeks ago.
• People who are at least 90 days past the end of their previous radiation treatment.
• People whose side effects from previous treatments have largely resolved to a mild level or less before joining the trial.
• People who have either stopped taking steroid medications or are on a very low, stable dose at the time of joining.
• People who are suitable candidates for a surgical procedure to collect a sample of tumor tissue for use in preparing the study treatment.
• People who have had a brain MRI scan with contrast dye done before surgery (within 28 days before joining) and will also have one done after surgery.
• People with a functional ability score (called Karnofsky Performance Status, or KPS) of 60 or above — including people who use a wheelchair but are otherwise mobile.
• People whose blood test results meet the following minimum levels: enough white blood cells (neutrophils ≥ 1,500), platelets ≥ 100, and hemoglobin above 8 g/dL, without needing recent blood transfusions or support.
• People whose kidney function tests (BUN and creatinine) are within acceptable ranges.
• People whose liver function tests (bilirubin, ALT, and AST) are within acceptable ranges.
• People who are able to give informed consent to participate.
• Women who could become pregnant must have a negative pregnancy test at the time of joining.
• Women who could become pregnant must be willing to use an accepted form of contraception throughout the study and for at least 24 weeks after the last dose of the study treatment.
• Men with female partners who could become pregnant must agree to use an approved form of contraception throughout the study and for 24 weeks after the last dose of the study treatment.

Who may not be able to join:

• People who have previously been treated with a drug called bevacizumab.
• People with a known active infection currently requiring antiviral or antibiotic treatment, or a condition that significantly weakens the immune system.
• People whose tumor has come back in more than one separate area of the brain at the same time (confirm with trial site for exact definition).
• People with seizures that are not well controlled.
• People who have received any live vaccine within 30 days before joining.
• People whose tumor is located primarily in the brainstem or spinal cord.
• People with serious, active health conditions, including: unstable angina or heart failure requiring hospitalisation; unstable heart rhythm problems or a heart attack within the past 6 months; a severe bacterial or fungal infection requiring intravenous treatment; a serious lung condition requiring hospitalisation; liver failure causing jaundice or clotting problems; AIDS (as defined by current CDC guidelines); autoimmune diseases being managed with immune-suppressing medications; or major physical or mental health conditions that the study doctor believes would prevent safe participation.
• Women who are pregnant or breastfeeding.
• People currently taking part in another clinical trial or who have received another experimental treatment within 30 days before the planned first dose of the study treatment.
• People who are unwilling or unable to receive the treatment and attend required follow-up visits.

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