5-Aminolevulinic acid (5-ALA) in children and adolescents with different types of brain tumours

Phase 1

• Conditions: supratentorial intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.); MedDRA version: 20.0Level: LLTClassification code 10006154Term: Brain tumor NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005669-54-NL
• Lead Sponsor: Westfälische Wilhelms-Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Recht u. Drittmittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-27
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age 3 - <18 years
• First radiological diagnosis of intra-axial, supratentorial contrast-enhancing tumor on MRI or recurrent supratentorial intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.)
• Resection is part of therapeutic strategy with an emphasis on neurological safety
• Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study. Patients that are able to understand should provide assent to participate in the trial
• Female adolescents: not pregnant (pregnancy test required for adolescents of childbearing age) and not breast-feeding.
Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Posterior fossa tumors
• Extra-axial tumors such as craniopharyngeoma
• Germ cell tumor or entities precluding surgical resection
• Acute or chronic porphyria
• Hypersensitivity to 5-ALA or porphyrins
• Renal insufficiency: serum creatinine > 2x upper limit of normal
• Hepatic insufficiency: serum bilirubine > 2x upper limit of normal, serum ?-GT > 2,5 x upper limit of normal, alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 upper limit of normal
• Blood clotting: INR out of acceptable limits
• Other malignant disease
• Patients with pre-existing cardiovascular diseases
• Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
• Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified