Early 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 a consent form agreeing to take part in the study.
• Adults aged 18 or older.
• People who have been diagnosed with glioblastoma (a type of brain tumour), confirmed by laboratory analysis of tissue taken during surgery or biopsy.
• People taking steroid medicines (such as dexamethasone) must have been on a stable or reducing dose of no more than 4 mg per day (or an equivalent amount) for at least 7 days before the study treatment begins.
• People whose recent blood tests (taken within the past 14 days) show that their bone marrow, kidneys, liver, and blood clotting are working at adequate levels (the trial site can confirm the specific values required).
• People whose brain tumour has been confirmed to have grown or returned after previous treatment, based on specific brain scan (MRI) measurements, and who have at least one measurable area of tumour visible on MRI of a certain minimum size (confirm with trial site for exact measurements).
• People who are having a special device called an Ommaya reservoir surgically placed for treatment delivery must have had the surgery completed at least 2 weeks before starting the study treatment, with no complications, and must have had a follow-up MRI at least 2 weeks after the surgery.
• People whose tumour has shown uptake on a specific type of scan called a NOTA-PRGD2 PET/CT scan, performed after the tumour returned and before the study treatment begins.
• People with a life expectancy of more than 6 months.
• People who are still able to carry out some self-care and are not completely disabled, as measured by a standard medical scale (Karnofsky Performance Status score of 50 or above).

Who may not be able to join:

• People who are currently receiving any other treatment specifically for glioblastoma outside of this trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed from the start of treatment until 6 months after treatment ends.
• People who are unwilling to use effective contraception during sexual activity from the time of signing the consent form until 6 months after the last dose of the study drug.
• People who are unable to tolerate medical scans, repeated blood draws, or who have very poor vein access.
• People with significant heart problems or a history of serious heart conditions, including: a heart attack, chest pain (angina), heart muscle disease, or heart bypass surgery within the past 6 months; certain abnormal heart rhythms or electrical patterns on a heart tracing (ECG); a heart pumping function below 50% on ultrasound; or uncontrolled high blood pressure (confirm with trial site for specific values and full list of heart-related criteria).
• People who have had another cancer within the past 5 years, with some exceptions such as certain fully treated skin cancers, cervical pre-cancers, or thyroid cancers (the trial site can confirm which prior cancers may still allow participation).
• People with certain abnormal results on blood tests for infections including hepatitis B, hepatitis C, syphilis, or HIV — though some people with inactive or treated hepatitis B or C may still be eligible (confirm with trial site).
• People who have received the drug bevacizumab for their glioblastoma or for managing symptoms such as brain swelling within the past 60 days.
• People whose tumour progressed within the first 12 weeks after completing radiotherapy.
• People who have previously received any drug treatment delivered directly into the brain or tumour before this study's treatment.
• People with active bleeding inside the brain or tumour, detected by a CT or MRI scan.
• People who have had a seizure within the past 14 days, or whose epilepsy or raised pressure in the brain is not controlled by medication.
• People with severe suppression of bone marrow function from previous cancer treatment that has not recovered adequately (confirm with trial site for specific recovery timeframes).
• People who received a blood transfusion within the past 4 weeks in order to meet the blood test requirements for this trial.
• People with a known allergy or sensitivity to any ingredient of the study drug or similar medicines.
• People with serious disease affecting the heart, lungs, brain, kidneys, liver, or other organs that, in the treating doctor's judgement, may put them at increased risk.
• People who have had an active infection requiring intravenous antibiotics within the past 4 weeks, or any other uncontrolled active infection considered significant by the treating doctor.
• People with a history of drug or alcohol misuse within the past year, long-term substance use, or a psychiatric condition that may affect their ability to follow the study requirements.
• People who have taken part in another clinical trial of an experimental drug or device within the past 4 weeks.

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