A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
This study is ongoing, but not recruiting participants.
Sponsor:
Legacy Health System
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jefferson W Chen, MD, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01403311
First received: July 25, 2011
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioma |
Drug: 5-Aminolevuline Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain |
Resource links provided by NLM:
Further study details as provided by Legacy Health System:
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ALA
5-Aminolevuline Acid (ALA)
|
Drug: 5-Aminolevuline Acid
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403311
Locations
| United States, Oregon | |
| Legacy Health System | |
| Portland, Oregon, United States, 97210 | |
Sponsors and Collaborators
Legacy Health System
DUSA Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Jefferson Chen, MD, PhD | Legacy Health System |
More Information
No publications provided
| Responsible Party: | Jefferson W Chen, MD, Principal Investigator, Legacy Health System |
| ClinicalTrials.gov Identifier: | NCT01403311 History of Changes |
| Other Study ID Numbers: | 5-ALA-01 |
| Study First Received: | July 25, 2011 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Legacy Health System:
|
Anaplastic astrocytoma Astrocytoma Brain stem glioma Ependymoma Glioblastoma Glioblastoma multiforme |
Gliosarcoma oligodendroglioma Medulloblastoma Mixed astrocytoma-ependymoma ALA |
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 May 21, 2013