The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours (P5A)

University College London (UCL)

Status and phase: Not yet enrolling; Phase 2

Conditions: Brain Tumor

Treatments: Drug: 5-ALA (Gliolan)

Study type: Interventional

Funder types: Other

Identifiers

NCT06678867

CCLGA 2022 27 Dandapani (Other Grant/Funding Number)

UCL/154416

Details and patient eligibility

About

The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour.

Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.

Enrollment: 80 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Magnetic Resonance Imaging confirmation of diagnosis consistent with either: primary presentation of high grade brain tumour OR patient relapsing with previously confirmed ependymoma or high-grade glial tumour

• Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours

• Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement

• 3 - 18 years inclusive

• Adequate liver and kidney function

  • creatinine - less than one and a half times the upper limit of normal.
  • haemoglobin above the lower limit of normal
  • Alanine transferase or Aspartate transferase less than twice the upper limit of normal (if both performed, then both results must be lower than twice the upper limit of normal
  • bilirubin lower than one and a half times the upper limit of normal

• Normal Coagulation profile

  o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits

• Urine porphyrin - Test to be completed and sent for analysis

• Blood pressure lower than or equal to the upper limit of normal

• Negative pregnancy test in women of childbearing potential*

• Informed Consent *A positive pregnancy test that is suspected to be due to the location of the tumour is to be queried with the TMG prior to registration of the patient

Exclusion criteria

• Patients with low grade tumours (either radiological or histological diagnosis)
• Patient is appropriate for biopsy only, based on Investigator and MDT judgement
• Known history (including family history) of porphyria
• Hypersensitivity to the active substance or to porphyrins
• History of light sensitivity reactions
• Pregnant or breastfeeding women

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Patients with high grade brain tumours

Other group

Description:

This is a single-arm study with two cohorts

Treatment:

Drug: 5-ALA (Gliolan)