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 have been diagnosed with a high-grade brain or central nervous system (CNS) tumour (classified as WHO grade III or IV) or a meningioma (any grade) that has come back, is getting worse, or has not responded to treatment.
• People with a type of childhood brainstem tumour called DIPG, where a biopsy has confirmed a grade II–IV infiltrating glioma, may also be considered eligible.
• For Phase I: people who are at least 4 years old and under 12 years old at the time of joining.
• For Phase II: people who are between 12 and 39 years old (inclusive) at the time of joining.
• People whose tumour shows up on a special scan called a DOTATATE PET/CT, with a result of 2 or higher on the Krenning scoring scale (this is confirmed by a central radiology review).
• People who have already received standard treatment for their tumour (and for meningioma, this includes at least surgery or radiation).
• People who have recovered from serious side effects of previous treatments before joining (side effects must be at or below grade 1 severity).
• People who received their last dose of standard chemotherapy at least 21 days before joining (or at least 42 days if the chemotherapy was a type called nitrosourea).
• People who received their last dose of a biological or investigational (experimental) anti-cancer agent at least 7 days before joining, and who have recovered from any related side effects.
• People who received their last dose of a monoclonal antibody or a drug with a long half-life at least 28 days before joining, and who have recovered from any related side effects.
• People who finished a large course of radiation (such as craniospinal or total body irradiation) more than 3 months before joining, or finished a smaller focused radiation treatment more than 4 weeks before joining.
• People who had an allogeneic (donor) stem cell transplant at least 6 months before joining with no sign of active graft-versus-host disease, or an autologous (own cells) stem cell transplant at least 3 months before joining.
• People who have been off growth factor medicines (such as filgrastim or erythropoietin) for at least 1 week before joining (or 2 weeks for long-acting versions).
• People who have been off long-acting somatostatin analogue medicines for at least 4 weeks, and off short-acting versions (such as octreotide) for at least 24 hours before joining.
• People whose neurological symptoms (such as weakness or other nerve-related issues) have been stable for at least 1 week before joining; people with well-controlled seizures may also be eligible.
• People with a performance (ability to carry out daily activities) score of 50 or above on the appropriate scale for their age, assessed within 2 weeks of joining.
• People with adequate bone marrow function, meaning: neutrophil count of at least 1.0 × 10⁹ cells/L, platelets of at least 100 × 10⁹ cells/L without a recent transfusion, and haemoglobin of at least 8 g/dL.
• People with adequate kidney function, as measured by either a kidney filtration rate above 70 mL/min/1.73m², or a blood creatinine level within the acceptable range for their age and sex.
• People with adequate liver function, including normal-range bilirubin, liver enzymes (AST/ALT), albumin, and blood clotting measurements.
• People with adequate heart function, including a heart pumping strength (ejection fraction) of at least 55% on an echocardiogram, and normal blood electrolyte levels.
• People taking the steroid medication dexamethasone who have been on a stable or reducing dose for at least 1 week before joining, with a daily dose no higher than 2.5 mg/m².
• Female patients who could become pregnant must have a negative pregnancy test within 72 hours before receiving the first dose of the study treatment.
• People of childbearing or child-fathering potential who are willing to use an acceptable form of contraception (including abstinence) during treatment and for at least 7 months after finishing treatment (females) or 4 months after finishing treatment (males).
• People (or their parent or guardian) who are able to understand and willing to sign the informed consent form.
• Males and females of all races and ethnic backgrounds are eligible.

Who may not be able to join:

• People whose cancer has spread into the bone marrow.
• People whose tumour is considered "bulky," meaning it is causing dangerous brain shifts, is larger than 5 cm in one direction on certain MRI scans, or is causing significant pressure in the brain or spine, as determined by the site investigator.
• People who are currently breastfeeding.
• People who have a history of another cancer, unless that previous cancer has been in remission for at least 5 years — except where the other cancer resulted in a secondary brain tumour.
• People with a serious unrelated illness (such as a significant infection, or major heart, lung, or liver problems) that, in the investigator's opinion, could affect their ability to safely participate.
• People with type 1 diabetes.
• People who are currently receiving any other anti-cancer treatment or taking part in another drug trial.
• People who have previously been treated with lutetium-177 DOTATATE/TOC or yttrium-90 DOTATATE/TOC.
• People who are incarcerated (prisoners).
• People who, in the investigator's opinion, are unlikely or unable to attend required follow-up visits or follow the study plan.

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