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:

• People who are 18 years of age or older at the time of joining the study
• People who have been confirmed by laboratory tissue analysis to have a recurring glioblastoma brain tumour (a specific high-grade brain cancer) that is located in the upper part of the brain
• People whose general health and ability to carry out daily activities meets a minimum functional score, as assessed by a doctor (known as a Karnofsky Performance Score of 70% or above)
• People whose blood tests before the biopsy show healthy enough levels of red blood cells (haemoglobin of at least 9 g/dl)
• People whose platelet count (cells that help blood clot) is at least 100,000/µl without support; a higher platelet count of at least 125,000/µl is required before any biopsy or catheter procedure, which may be achieved with a platelet transfusion if needed
• People whose white blood cell (neutrophil) count is at or above 1,000 before the biopsy
• People whose kidney function blood test result is within an acceptable range (creatinine no more than 1.5 times the upper limit of normal) before the biopsy
• People whose liver function blood test results are within acceptable ranges before the biopsy — specifically, total bilirubin no more than 1.5 times the upper limit of normal (or up to 3 times the upper limit of normal if a condition called Gilbert's Syndrome is known or suspected and supported by additional testing), and liver enzyme levels (AST/ALT) no more than 2.5 times the upper limit of normal
• People whose blood clotting test results are within an acceptable range before the biopsy; people with a history of blood clots may still be considered, with anticoagulation medication managed by the surgical team around the time of the procedure (confirm with trial site)
• People whose recurring tumour is confirmed by tissue analysis at the time of the biopsy, before the first treatment is given
• People who are able to have a brain MRI scan with and without contrast dye
• People who have previously completed the standard childhood vaccination series against polio, and who have also received a specific booster vaccine (trivalent Inactivated Poliovirus Vaccine, IPOL®) at least 1 week but no more than 6 weeks before receiving the study treatment; people who are unsure of their vaccination history must provide evidence of immunity against polio before joining
• People who, or whose partner, either cannot become pregnant (due to not being sexually active, being post-menopausal, or having had a surgical procedure such as a hysterectomy, vasectomy, or tubal ligation), or who agree to use an approved form of contraception during the study (such as hormonal contraception, an intrauterine device, or a barrier method with spermicide)
• People who are able to read, understand, and sign the informed consent form approved by the ethics review board

Who may not be able to join:

• People who are pregnant or breastfeeding
• People whose condition shows signs of a life-threatening brain pressure emergency, as assessed by the study's neurosurgeons
• People with a serious active infection currently being treated with intravenous antibiotics, or who have an unexplained fever
• People with a known disease that weakens the immune system, or who are known to have HIV
• People with unstable or serious ongoing medical conditions, such as severe heart disease (classified as New York Heart Association Class 3 or 4)
• People with known significant lung disease (with breathing capacity below a certain level) or uncontrolled diabetes
• People with a known allergy to albumin (a protein used in the treatment process)
• People with a history of agammaglobulinemia (a rare condition where the body cannot produce certain immune proteins)
• People who have received chemotherapy or the drug bevacizumab too recently before starting the study — specific waiting periods apply depending on the type of chemotherapy used (confirm exact timeframes with trial site), unless side effects from that treatment have fully resolved
• People who have received immunotherapy within 4 weeks before starting the study drug, unless side effects have fully resolved
• People who have received tumour treating fields therapy (such as Optune®) within 1 week before starting the study drug
• People who have received radiation therapy less than 12 weeks before joining, unless there is clear evidence of the tumour growing beyond the treated area, two consecutive scans at least 4 weeks apart showing progression, or tissue confirmation of progression
• People who have not yet completed all standard treatments for their tumour, including surgery and radiation therapy; whether prior chemotherapy is required depends on a specific tumour marker called MGMT promoter methylation status (confirm with trial site)
• People whose tumour is located in the brainstem, cerebellum, or spinal cord; or whose imaging shows the tumour actively growing in multiple locations, spreading extensively along the inner lining of the brain's fluid spaces, crossing to the other side of the brain, or spreading to the membranes surrounding the brain or spinal cord
• People who have been taking more than 4 mg per day of the steroid dexamethasone within the 2 weeks before the first treatment
• People with a worsening muscle weakness condition related to long-term steroid use (steroid myopathy)
• People who are currently receiving active treatment for a separate, unrelated cancer — exceptions may apply for certain skin cancers or early-stage cervical conditions (confirm with trial site)
• People with an active autoimmune disease that has required immune-suppressing treatment within the past 3 months
• People with a known allergy to the chemotherapy drugs lomustine or dacarbazine, or to any ingredients in lomustine

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