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 aged 18 years or older.
• People who have been diagnosed with glioblastoma (a type of brain tumour) that has come back, confirmed by tissue testing or brain scan, with tumour lesions of a certain size (no larger than 3 cm on a contrast MRI scan taken before the study drug is given).
• People whose brain tumour type matches the 2021 World Health Organization classification for glioblastoma, confirmed by tissue testing.
• People whose glioblastoma has returned or stopped responding after standard treatment (surgery followed by radiation therapy and chemotherapy with a drug called temozolomide), or who were unable to tolerate that standard treatment.
• People who are medically able to have a small device called an Ommaya reservoir catheter implanted into the tumour area of the brain.
• People with a general health and function score of 70 or above on the Karnofsky Performance Scale, and an expected survival of at least 3 months (confirm with trial site).
• People who have received a booster dose of inactivated poliovirus vaccine (a specific type of polio vaccine) between 1 week and 6 months before receiving the study drug, and whose blood test shows a sufficient level of polio-fighting antibodies before the study drug is given.
• People who are able to have a brain MRI scan both with and without contrast dye.
• People, and their partners, who have no plans to conceive a child from the screening period until 90 days after the end of the observation period, and who agree to use effective non-hormonal contraception throughout the trial.
• People who are willing to participate voluntarily, sign a consent form, follow the study procedures, and attend required follow-up appointments.

Who may not be able to join:

• People who have a known allergy to any ingredient in the study drug, to the contrast agent used in imaging (Maganweixian), or to albumin.
• People who have a life-threatening condition where the brain is being compressed inside the skull (cerebral hernia syndrome), as assessed by the treating doctor.
• People with a serious active infection that requires treatment through a drip, or an unexplained fever lasting more than one week.
• People with a known history of immune system deficiency (such as a positive HIV test), other inherited or acquired immune conditions, or who have had an organ transplant.
• People with unstable or severe heart conditions, classified as Class 3 or 4 by the New York Heart Association.
• People who have had a heart attack, unstable chest pain, stroke, or serious blood vessel disease within the past 6 months.
• People with uncontrolled high blood pressure (confirmed on at least two separate occasions as 160 mmHg or higher for the top reading, or 100 mmHg or higher for the bottom reading, despite blood pressure medication).
• People with active blood clots, active bleeding, or a medical condition that significantly increases the risk of bleeding (such as a clotting disorder).
• People with an active autoimmune disease that required systemic immune-modifying treatment within the past 3 months.
• People with a known history of a condition called agammaglobulinemia, where the body cannot produce certain immune proteins.
• People whose tumour is located in the brainstem, cerebellum, or spinal cord, or whose cancer has spread along the surface of the brain or spinal cord, or who have widespread disease along the inner lining of the brain cavities.
• People whose brain scans show that the tumour is growing into or has opened a pathway to the fluid-filled spaces inside the brain (ventricles), or whose tumour crosses the midline of the brain.
• People who have had neurological problems caused by a polio infection in the past.
• People with a worsening muscle weakness condition linked to steroid use, involving gradual weakening and shrinkage of the muscles closest to the body's core.
• People who are currently being treated for another unrelated cancer, except for certain non-invasive skin cancers or early-stage cervical conditions that have been adequately treated.
• People who have received cancer treatments (such as chemotherapy, targeted therapy, immunotherapy, electric field therapy, or other experimental cancer drugs) within 4 weeks before the first dose of the study drug (or within a longer period based on the specific drug used), and who have not yet recovered from the side effects of those treatments.
• People who have had radiation therapy within 12 weeks before the study drug is given, unless the radiation was for a new area of cancer growth outside the previously treated region.
• People who have been taking more than 5 mg per day of dexamethasone (a steroid) or an equivalent dose of another steroid within the 2 weeks before receiving the study drug (inhaled or topical steroids in people without autoimmune disease may be acceptable — confirm with trial site).
• People whose blood test results fall outside acceptable ranges, including low red blood cell levels, low platelet count, low white blood cell count, or abnormal kidney, liver, or clotting function results (confirm specific values with trial site).
• People who test positive for syphilis, or who have active hepatitis B or hepatitis C based on specific blood test results.
• People who have received any vaccine within 4 weeks before the study drug is given, except for inactivated polio vaccine, non-live seasonal flu vaccines, inactivated COVID-19 vaccines, or mRNA COVID-19 vaccines.
• People who are pregnant or breastfeeding, or women of childbearing age who test positive on a pregnancy test within 7 days before starting treatment.
• People who the trial investigator considers unsuitable for participation for any other reason.

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