5-Aminolevulinic acid (5-ALA) in children and adolescents with differnt types of brain tumours
- Conditions
- 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: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005669-54-DE
- Lead Sponsor
- niversität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Personal und Recht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
• Age 3 - <18 years
• First radiological diagnosis of intra-axial, contrast-enhancing tumor on MRI or recurrent 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
• Extra-axial tumors such as craniopharyngeoma
• Tumors 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
- Primary Outcome Measures
Name Time Method Main Objective: To determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with intra-axial brain tumors;Secondary Objective: 1. To determine whether fluorescing tissue truly signifies tumor (positive predictive value)<br>2. To determine extent of tumor resection on early post-operative MRI<br>3. Pharmacokinetics of 5-ALA in children and adolescents;Primary end point(s): Toxicological and clinical safety by measuring the incidence of adverse events of CTCAE grade III, IV or V (excluding chemotherapy-associated toxicities) during and after 5-ALA fluorescence-guided resections in children and adolescents with unifocal, contrast-enhancing intra-axial brain tumors (first diagnosis with unknown history, recurrent with malignant neuroepithelial histology)<br><br>;Timepoint(s) of evaluation of this end point: Adverse events will be documented continuously from day of operation to 6 weeks afterwards.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 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 after 5-ALA-administration);Timepoint(s) of evaluation of this end point: 1. Biopsies are taken during the resection of the tumor<br>2. MRI is done until max. 72h post-OP <br>3. Samples for protoporphyrine IX analysis will be taken 3-6h, 6-9h, 9-12h after 5-ALA administration