Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

NCT02755142 | Completed Phase 1

• 1 other identifier: MC-ALS.8-I/GLI
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.

Conditions

Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).

  After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.

  Within 3 hours

Study Arms (3)

Dose level 1

ACTIVE COMPARATOR

0,2 mg/Kg

Biological: Gliolan

Dose level 2

ACTIVE COMPARATOR

2,0 mg/Kg

Biological: Gliolan

Dose level 3

ACTIVE COMPARATOR

20 mg/Kg

Biological: Gliolan

Interventions

Gliolan BIOLOGICAL

Also known as: 5-Aminolevulinic Acid Hydrochloride (5-ALA)

Dose level 1; Dose level 2; Dose level 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
• Indication for surgical tumour resection
• First operation of the tumour, no other tumour-specific pre-treatment
• Karnofsky Performance Scale 70%
• Patient's written informed consent
• Age 18-75 years

You may not qualify if:

• Porphyria, hypersensitivity to porphyrins
• Renal insufficiency:
• Creatinine \> 2.0 mg/dl
• Hepatic insufficiency:
• Bilirubin \> 3 mg/dl
• Quick test \< 60 %
• GT \> 100 U/I
• Other known malignancy (except basaliomas)
• Women:
• Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)
• Men:
• Inadequate contraception (condom)
• Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
• Simultaneous participation or participation in another clinical trial in the preceding 30 days

Sponsors & Collaborators

• medac GmbH: lead
• IKP: collaborator

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 28, 2016
• Study Start: February 1, 2000
• Primary Completion: June 1, 2001
• Study Completion: June 1, 2001
• Last Updated: May 23, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share