Phase 1 Cervical 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 at the time of joining the study.
• People who have been diagnosed with a specific type of aggressive brain tumour called Grade 4 IDH-wildtype Glioblastoma (or a high-grade brain tumour with similar molecular features), confirmed by laboratory testing of tumour tissue.
• People whose general health and ability to carry out daily activities meets a minimum level, as measured by a standard medical scoring tool called the Karnofsky Performance Score (a score of 70% or higher is required).
• People whose blood count levels meet minimum thresholds before the biopsy procedure — including haemoglobin (at least 9 g/dl), platelets (at least 100,000/µl generally, and at least 125,000/µl for the biopsy and catheter procedure, which can be reached with a platelet transfusion if needed), and neutrophils (at least 1,000).
• People whose kidney function, as measured by a blood test called creatinine, is within an acceptable range (no more than 1.5 times the upper limit of normal).
• People whose liver function blood test results are within acceptable ranges — including bilirubin (no more than 1.5 times the upper limit of normal, or up to 3 times the upper limit if a condition called Gilbert's Syndrome is suspected or confirmed) and liver enzymes 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 eligible if anticoagulation medication is managed appropriately around the time of surgery, as guided by the neurosurgical team (confirm with trial site).
• People who have had their tumour surgically removed 3 to 5 weeks before the study treatment is given, and where the return of the tumour has been confirmed by laboratory testing of tumour tissue.
• People who are able to have a brain MRI scan with and without contrast dye, and whose post-surgery MRI shows a remaining area of tumour that meets specific size requirements (no larger than 3 x 3 cm of a certain type of visible disease on the scan) suitable for the treatment delivery method used in this trial.
• People who either cannot become pregnant (due to age, surgery, or not being sexually active), or who agree to use an approved method of contraception during the trial — this applies to participants and/or their partners.
• People who are able to read, understand, and sign a consent form showing they understand the research nature of this study.

Who may not be able to join:

• People who are pregnant or breastfeeding (a pregnancy test will be done at the screening visit).
• People whose brain tumour is causing an immediately life-threatening risk of brain herniation, as assessed by the study neurosurgeons.
• People with serious, active other health conditions, including: an active infection requiring intravenous antibiotics or an unexplained fever; a known immune system disorder or HIV infection; severe heart disease (classified as New York Heart Association Class 3 or 4); significant lung disease (with a breathing test result below 50% of expected); uncontrolled diabetes; or a known allergy to albumin.
• People who have received chemotherapy or the drug bevacizumab within 4 weeks before starting the study treatment (or 6 weeks for a specific type called nitrosourea, or 1 week for certain low-dose daily chemotherapy), unless they have fully recovered from any side effects.
• People who have received immunotherapy within 4 weeks before starting the study treatment, unless they have fully recovered from any side effects.
• People who have received tumour treating fields therapy (such as Optune®) within 1 week before starting the study treatment.
• People who have completed radiation therapy less than 12 weeks before starting the study treatment, unless there is clear evidence the tumour has grown beyond the treated area, or progression has been confirmed by two scans at least 4 weeks apart, or by laboratory testing of tumour tissue.
• People who have not yet completed all standard treatments, including surgery and radiation therapy. Regarding chemotherapy: if the tumour has a specific genetic marker (unmethylated MGMT promoter), prior chemotherapy is not required; if the MGMT promoter is methylated or its status is unknown, at least one course of chemotherapy must have been completed before joining the trial.
• People whose tumour is located in certain areas of the brain or spine (brainstem, cerebellum, or spinal cord), or whose tumour shows signs of active spread across multiple areas, extensive spread along the inner lining of the brain cavities, growth across the centre of the brain, or spread to the membranes surrounding the brain and spinal cord.
• People who are taking more than 4 mg per day of the steroid medication dexamethasone within the 2 weeks before the study treatment infusion.
• People who have a worsening condition of muscle weakness caused by long-term steroid use.
• People who are currently receiving treatment for an unrelated cancer, with the exception of certain early-stage or skin cancers (cervical carcinoma in situ, or adequately treated basal or squamous cell skin cancer).
• People who have an active autoimmune disease that has required systemic immune-modifying treatment within the past 3 months.
• People who are unable to have an MRI scan due to body size or the presence of certain metal devices in their body (such as a pacemaker, infusion pump, metal aneurysm clips, metal prostheses, joint replacements, rods, or plates).

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