Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Parents or the patient (depending on age) have given written consent to participate.
• The patient is able to follow all the study procedures, in the opinion of the study doctor.
• The patient is between 1 and 18 years old.
• Female patients who are able to become pregnant have a negative pregnancy test before joining.
• The patient has been newly diagnosed with DIPG (a type of brainstem tumour) confirmed by MRI scan.
• The patient has a performance score of 50 or above — a measure of how well they are able to carry out daily activities — using the appropriate scale for their age (confirm with trial site).
• The tumour is located in a position that the study doctor considers safe to access for a biopsy procedure, and the treatment can be delivered without entering the fluid-filled spaces of the brain.
• The patient has not received any previous treatment for DIPG.

Who may not be able to join:

• People with serious infections or significant organ problems (such as severe kidney, liver, heart, or bone marrow failure), or who have a fever of 38°C or above at the start of the study.
• People who have taken part in another clinical trial or received another experimental medication within the 30 days before the trial treatment.
• People with a weakened immune system, an autoimmune disease, or active hepatitis.
• People with a medical or psychological condition that could interfere with participation, the ability to give informed consent, the ability to tolerate treatment, or that could mask side effects or significantly affect how the body processes the study drug.
• People whose tumour is found in more than one location in the brain.
• People who are pregnant or breastfeeding.
• People with severely reduced bone marrow activity.
• People whose liver enzyme levels (AST and/or ALT) or total bilirubin are more than three times the normal upper limit.
• People with a low neutrophil count (a type of white blood cell involved in fighting infection) below the required level.
• People with a low platelet count below the required level.
• People with low haemoglobin (a measure of red blood cell function) below the required level.
• People with Li-Fraumeni syndrome or a known inherited defect in the retinoblastoma gene or related biological pathways.
• People who have received any vaccine within the 30 days before the study treatment is given.
• People who have had a blood transfusion or received medications to treat low blood cell counts (such as G-CSF) within the 28 days before the start of the study.

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