Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid - Full Text View

Sponsor:	medac GmbH
Information provided by:	medac GmbH
ClinicalTrials.gov Identifier:	NCT00241670

Purpose

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Condition	Intervention	Phase
Brain Cancer Brain Tumors Cancer of Brain Primary Brain Tumors Brain Tumor, Primary	Drug: 5-aminolevulinic acid	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind
Official Title:	Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) Vs. Conventional Resection

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Further study details as provided by medac GmbH:

Primary Outcome Measures:

1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV –WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV –WHO).

Secondary Outcome Measures:

1. Overall survival.
2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
3. Volume of residual tumour
4. Toxicity after oral administration of 5-Aminolevulinic acid.
5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment

Estimated Enrollment:	270
Study Start Date:	October 1999

Detailed Description:

Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively.

Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.

Eligibility

Ages Eligible for Study:	18 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).
Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.
First operation of the tumour, no other tumour-specific pretreatment
Karnofsky at least 70 %
Patient’s written informed consent
Age 18-72 years

Exclusion Criteria:

Tumour location in the midline, basal ganglia, cerebellum or brain stem
More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases
Porphyria, hypersensitivity to porphyrins
Renal insufficiency: Creatinine > 2.0 mg/dl
Hepatic insufficiency: Bilirubin > 3 mg/dl
Quick test < 60 %
gamma-GT > 70 U/I
Malignancies other than basaliomas
Existing or planned pregnancy or lactation, or inadequate contraception
Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241670

Sponsors and Collaborators

medac GmbH

Investigators

Study Chair:

Hans-Juergen Reulen, MD

Ludwig-Maximilians - University of Munich

More Information

No publications provided by medac GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401.

ClinicalTrials.gov Identifier:	NCT00241670 History of Changes
Other Study ID Numbers:	MC-ALS.3/GLI
Study First Received:	October 18, 2005
Last Updated:	October 18, 2005
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Brain Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012