A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain (ALA)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Jefferson W Chen, MD, Legacy Health System.
Recruitment status was: Active, not recruiting
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jefferson W Chen, MD, Legacy Health System
First received: July 25, 2011
Last updated: March 24, 2014
Last verified: March 2014
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
Drug: 5-Aminolevuline Acid
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Primary Outcome Measures:
- Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively [ Time Frame: participants will be followed while in the hospital and for 12 weeks after surgery ]
Secondary Outcome Measures:
- Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA [ Time Frame: participants will be followed for 24 months ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
5-Aminolevuline Acid (ALA)
Drug: 5-Aminolevuline Acid
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
- Patients may have prior therapy
- 18 years of age
- Male or Female
- Life expectancy is not a consideration for protocol entry
- Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Confirmation of Glial Tumor
- Gross total resection is the aim of surgery
- Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.
- Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
- Tumor with perforating vessels
- Tumor involves critical fiber tracks
- Use of the microsurgical tool monopolar loop
- Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
- Performance Status of less than 60
- Prior therapy is not an exclusion criterion
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
- Personal or family history of porphorias
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403311
|Legacy Health System
|Portland, Oregon, United States, 97210 |
Legacy Health System
DUSA Pharmaceuticals, Inc.
||Jefferson Chen, MD, PhD
||Legacy Health System
||Jefferson W Chen, MD, Principal Investigator, Legacy Health System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 25, 2011
||March 24, 2014
Keywords provided by Jefferson W Chen, MD, Legacy Health System:
Brain stem glioma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 21, 2017
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases