Trial | NCT02755142  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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.
Study Started
Feb 29
2000
Primary Completion
Jun 30
2001
Study Completion
Jun 30
2001
Last Update
May 23
2016
Estimate

Biological Gliolan

  • Other names: 5-Aminolevulinic Acid Hydrochloride (5-ALA)

Dose level 1 Active Comparator

0,2 mg/Kg

Dose level 2 Active Comparator

2,0 mg/Kg

Dose level 3 Active Comparator

20 mg/Kg

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted