Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with supratentorial brain tumors

Phase 2

• Conditions: brain tumors; Supratentorial; 10029211

• Registration Number: NL-OMON52327
• Lead Sponsor: Westfälische Wilhelms-Universität Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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, astroblastoma,
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
child-bearing age) and not breast-feeding (for at least 24 hours after Gliolan
intake). 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.

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 (ULN).
- Hepatic insufficiency: serum bilirubine > 2x ULN, serum γ-GT > 2,5 x ULN,
alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 ULN.
- 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Toxicological and clinical safety by measuring the incidence of adverse events<br /><br>of CTCAE grade III, IV or V (excluding chemotherapy-associated toxicities)<br /><br>during and after 5-ALA fluorescence-guided resections in children and<br /><br>adolescents with unifocal, supratentorial, contrast-enhancing intra-axial brain<br /><br>tumors, (first diagnosis with unknown histology, recurrent with malignant<br /><br>neuroepithelial histology).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. True positive rate of fluorescence for indicating tumor.<br /><br>2. Extent of resection as assessed on early post-operative MRI<br /><br>3. Pharmacokinetics (determination of protoporphyrin IX 3 times within 12h<br /><br>after 5-ALA administration)</p><br>