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:

• People who have signed and dated a consent form agreeing to take part
• People aged 12 years or older at the time of signing the consent form
• People who have been diagnosed with a specific type of recurring brain tumour (a high-grade astrocytoma confirmed by tissue testing, including glioblastoma or gliosarcoma, that has come back after previous treatment), and who have previously received radiation therapy and a chemotherapy drug called temozolomide
• People whose original brain tumour was a lower-grade type (grade 2 or 3) that has since been confirmed to have returned as a higher-grade tumour (grade 4)
• People who score above 70 on a standard measure of physical functioning used by doctors to assess how well a person can carry out daily activities (for those under 16 years old, a similar child-appropriate scale is used)
• People who are at least 12 weeks past the end of their focused radiation treatment, unless specific medical criteria for early tumour progression are met
• People who have had a brain MRI scan with advanced brain tumour imaging completed within 30 days before joining the study
• People who have had recent brain surgery, provided at least 3 weeks have passed since a full resection or at least 1 week since a biopsy, and they have recovered from any complications
• People whose blood counts and blood cell levels meet the minimum thresholds required for the trial (confirm with trial site)
• People whose liver function test results are within the acceptable range for the trial (confirm with trial site)
• People whose kidney function is within the acceptable range for the trial (confirm with trial site)
• Women who could potentially become pregnant and who have had a negative pregnancy blood test within 14 days before joining the study
• Women who could potentially become pregnant and who are willing to use 2 methods of contraception, or to abstain from heterosexual activity, during the study and for 3 months after the last treatment dose
• Men who are willing to use 2 methods of highly effective contraception from the first treatment dose and for 3 months after the last dose
• For the surgical group only: people who have at least 1 cm² of tumour visible on scans that a neurosurgeon considers suitable for surgical removal

Who may not be able to join:

• People who have previously been treated with Gliadel (a chemotherapy wafer placed in the brain) or bevacizumab (a targeted drug therapy)
• People who have previously had certain types of localised brain treatments, including implanted chemotherapy, brachytherapy, or treatments delivered directly into the brain tissue
• People currently taking part in, or who have taken part in, another clinical trial involving an experimental cancer treatment or device within the past 4 weeks, or who plan to use the Optune® device during this trial
• People with a known severe allergic reaction to monoclonal antibodies, a history of anaphylaxis (a severe allergic reaction), or uncontrolled asthma in the past 5 months
• People with a known history of HIV, HTLV1, HTLV2, active Hepatitis B, or active Hepatitis C (note: people who have been vaccinated against Hepatitis B are not excluded)
• People diagnosed with an immune system deficiency, or who are currently taking medications that suppress the immune system within 7 days before joining the study
• People who have received chemotherapy or certain targeted drug treatments within 2 weeks before the study start date (some exceptions may apply — confirm with trial site)
• People who have had radiation therapy less than 12 weeks before joining the study, unless specific medical criteria for early tumour progression are met
• People who have received certain immune checkpoint therapies (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments) within the 3 months before joining the study
• People who have another cancer that is actively growing or currently being treated (some minor skin cancers or early-stage cervical cancer that has been treated may be exceptions — confirm with trial site)
• People whose tumour has spread throughout the brain in a diffuse pattern, has spread outside the brain, or is located primarily in the brainstem or spinal cord
• People whose brain MRI shows the brain's midline has shifted more than 0.5 cm, or shows signs of dangerous brain pressure
• People whose tumour is larger than 5 cm at its widest point
• People with an active autoimmune disease that has required systemic treatment within the past 3 months, or a history of a severe autoimmune condition requiring ongoing steroids or immune-suppressing medications (some milder conditions such as vitiligo, controlled thyroid conditions, or Sjögren's syndrome may not be excluded — confirm with trial site)
• People with interstitial lung disease or active non-infectious lung inflammation
• People with an active infection that requires systemic treatment, or that the trial doctor believes could interfere with the study
• People with any medical condition, treatment history, or test result that the treating doctor believes would make participation unsafe or affect the study results
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the study requirements
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period or within 3 months after the last treatment dose
• People who have received a live vaccine within 30 days before the first treatment dose
• People who are unable to have MRI scans
• People with known bleeding disorders or blood clotting problems
• People on full-dose blood-thinning or anti-clotting medications that cannot be temporarily stopped
• People whose baseline MRI shows significant fresh bleeding in the brain (greater than 1 cm in diameter)
• People who have had an organ transplant or stem cell transplant that requires ongoing immune-suppressing medication (some transplants that do not require such medication, such as corneal or hair transplants, may not be excluded — confirm with trial site)
• People whose tumour has multiple separate sites of growth in the brain that are not connected and would require separate radiation fields to treat (some closely connected satellite tumours may be permitted — confirm with trial site)

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