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:

For adults with GBM (Group 1):

• People aged 21 years or older
• People with a newly diagnosed brain tumour called glioblastoma (GBM, Grade IV), confirmed by laboratory testing, that has a specific molecular feature called MGMT low or unmethylated — this is not a tumour that came from a cancer elsewhere in the body or a returning tumour
• The tumour must be located in the upper part of the brain (above the brainstem)
• Tumour tissue must have been collected during surgery in a way that allows it to be processed for the study's special treatment
• After surgery, the remaining tumour must measure no more than 3 cm on a brain scan (MRI)
• People who have recovered from surgery and any related complications
• Brain scans (MRI with contrast dye) must have been done both before and after surgery, within specific timeframes (before surgery: within 28 days of joining the study; after surgery: within 7 days of the operation)
• People with a general health and function score of 60 or above on a standard medical scale (people in wheelchairs due to paralysis may still meet this requirement)
• Blood counts and organ function within acceptable ranges: enough white blood cells, platelets, and red blood cells; kidneys and liver working adequately (confirm specific values with trial site)
• Willingness to take an anti-seizure medication (such as levetiracetam) throughout the vaccination part of the study
• Ability to give written consent, or having a legal representative do so if needed
• Women who could become pregnant must have a negative pregnancy test at the time of joining
• Women who could become pregnant must agree to use an approved method of contraception throughout the study and for at least 24 weeks after the last dose of study treatment
• Men with female partners who could become pregnant must agree to use approved contraception throughout the study and for at least 24 weeks after the last dose
• Any neurological problems remaining after surgery must have been stable for at least one week before joining

For children and young people with high-grade brain tumours (Group 2):

• People aged over 3 and up to 25 years old
• People with a newly diagnosed high-grade brain tumour (Grade III or IV), confirmed by laboratory testing
• Tumour tissue must have been collected during surgery in a way that allows it to be processed for the study's special treatment
• After surgery, the remaining tumour must measure no more than 3 cm on a brain scan (MRI)
• People who have recovered from surgery and any related complications
• Brain scans (MRI with contrast dye) must have been done both before and after surgery, within specific timeframes (before surgery: within 28 days of joining; after surgery: within 7 days of the operation)
• People with a general health and function score of 60 or above on the appropriate scale for their age (wheelchair users due to paralysis may still meet this requirement)
• Blood counts and organ function within acceptable ranges, including adequate white blood cells, platelets, red blood cells, kidney function, and liver function (confirm specific values with trial site)
• People receiving steroid medications must be on a stable or reducing dose for more than one week before joining, and the dose must be within a specified limit (confirm with trial site)
• Willingness to take an anti-seizure medication (such as levetiracetam) throughout the vaccination part of the study
• A parent, legal guardian, or the participant themselves (where appropriate) must be able to understand and sign the consent documents
• Female participants who could become pregnant must have a negative pregnancy test at the time of joining
• Female participants who could become pregnant must agree to use an approved method of contraception throughout the study and for at least 24 weeks after the last dose
• Male participants who could father a child must agree to use approved contraception throughout the study and for at least 24 weeks after the last dose
• Any neurological problems remaining after surgery must have been stable for at least one week before joining
• Participants may need to be enrolled in a separate related study (PNOC COMP) before joining this one, if that study is available at the treating centre (confirm with trial site)

Who may not be able to join:

For adults with GBM (Group 1):

• People who have had another type of cancer in the past, unless they have been cancer-free for 3 or more years (some early-stage or non-invasive cancers may still be eligible — confirm with trial site)
• People whose tumour has a methylated MGMT marker
• People with a specific type of widespread brain tumour called Gliomatosis Cerebri
• People whose tumour has spread to the lower parts of the brain, outside the skull, or to the lining of the brain and spinal cord
• People with a returning or multi-site brain tumour
• People with remaining tumour larger than 3 cm after surgery
• People who are HIV positive or have Hepatitis B or Hepatitis C
• People with a known active infection or a condition that weakens the immune system
• People who need corticosteroid (steroid) medication at doses above a low maintenance level, or who have not reduced to low-dose steroids within one week before scheduled vaccinations
• People who have previously had chemotherapy or radiation-sensitising treatments to the head or neck area (other than standard TMZ chemotherapy given during radiation for GBM)
• People who have previously had radiation treatment to the head or neck that would overlap with new radiation fields, or who have had radiosurgery
• People with serious ongoing health conditions, including unstable heart problems, serious heart rhythm problems or heart attack in the last 6 months, active bacterial or fungal infection requiring intravenous antibiotics, serious breathing problems, liver failure with jaundice or clotting problems, AIDS, autoimmune disease managed with immune-suppressing medications, major psychiatric conditions, active connective tissue disorders such as lupus or scleroderma (confirm with trial site)
• Women who are pregnant or breastfeeding
• People with a history of a nerve condition called brachial neuritis or Guillain-Barré syndrome
• People currently taking part in another clinical trial or who have received experimental treatment within 30 days before joining
• People who are unwilling or unable to complete the treatment and follow-up visits

For children and young people with high-grade brain tumours (Group 2):

• People with specific tumour types: diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or tumours with a particular genetic change called BRAFV600E
• People with a large or widespread tumour causing significant pressure in the brain or spine, involving more than 3 lobes of the brain, or that has spread outside the skull
• People who are HIV positive or have Hepatitis B or Hepatitis C
• People with seizures that are not well controlled
• People with a history of heart muscle inflammation (myocarditis)
• People who have received a live vaccine within 30 days before joining
• People with a known active infection or a condition that weakens the immune system
• People with significant problems affecting the kidneys, heart, lungs, liver, or other major organs
• People with serious or unstable ongoing medical conditions
• Women who are pregnant or breastfeeding
• People currently taking part in another clinical trial or who have received experimental treatment within 30 days before joining
• People who are unwilling or unable to complete the treatment and follow-up visits

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