Brain Cancer Trial, Recruiting NCT05839379 Sponsor: Nationwide Children's Hospital Condition: Brain Cancer
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Brain Cancer Trial, Recruiting

NCT05839379
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 12 months and 39 years of age at the time of joining the screening process
  • People who have been newly diagnosed with a high-grade brain tumour (including a type called DIPG), where the diagnosis has been confirmed through a biopsy or surgical removal of tumour tissue and reviewed by a pathologist at the treating hospital
  • People diagnosed with DIPG must have a tumour centred in a specific part of the brainstem (the pons) that affects at least two-thirds of it, confirmed as a certain type of brain tumour under standard medical classification
  • People with other high-grade brain tumours (not DIPG) must have a tumour classified as the most serious grades (WHO grade 3 or 4)
  • People do not need to have a measurable tumour to be eligible
  • People whose cancer has spread to other areas of the brain or spine, or who have tumours in multiple locations, may still be eligible
  • People with a tumour starting in the spine may be eligible
  • People whose high-grade brain tumour developed as a result of previous radiation treatment may be eligible
  • People who have had surgery, radiation therapy, steroid medication (dexamethasone), or a specific chemotherapy (temozolomide given alongside radiation) before joining may be eligible
  • People who have previously received a drug called bevacizumab (Avastin) may be eligible (confirm with trial site regarding timing requirements)
  • People must be enrolled within specific timeframes relative to diagnosis and completion of radiation therapy, depending on which screening pathway is used (confirm with trial site for exact timing requirements)
  • People must have tumour tissue available for molecular testing, or results from previous detailed tumour genetic testing, submitted according to the screening pathway being used
  • A parent, legal guardian, or the patient themselves must be willing and able to sign a consent form; age-appropriate agreement from the patient will also be sought where suitable

Who may not be able to join:

  • People whose tumour does not meet the specific definitions of high-grade brain tumour or DIPG described above
  • People who have received any other cancer treatment (beyond surgery, radiation, dexamethasone, temozolomide with radiation, or bevacizumab) for their high-grade brain tumour
  • People being considered for the lorlatinib treatment arm who have already received radiation therapy
  • People whose radiation therapy began more than 42 days after their surgery or biopsy (confirm with trial site, as earlier start times are strongly recommended)

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Maryam Fouladi, MD, Nationwide Children's Hospital

Phone: 16147223284

Australian sites

Sydney Children's Hospital, Randwick, New South Wales
+61293821730
Queensland Children's Hospital, South Brisbane, Queensland
+61730683593
Royal Children's Hospital, Melbourne, Victoria
+61 3 9345 5479
Perth Children's Hospital, Perth, Western Australia
+61864560241

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Nationwide Children's Hospital
Registry
ClinicalTrials.gov
Start date
2 August 2024
Est. completion
28 August 2029

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇩🇪 Germany 🇳🇱 Netherlands 🇳🇿 New Zealand 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Molecular profiling; Feasibility of molecular profiling and enrollment to a TarGeT treatment protocol

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov