Clinical trial · Interventional
A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
NCT01403311CI-TRIAL-00014107ALAunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevuline Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALA
- description
- 5-Aminolevuline Acid (ALA)
- interventionNames
- Drug: 5-Aminolevuline Acid
Primary outcomes (1)
- measure
- Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
- timeFrame
- participants will be followed while in the hospital and for 12 weeks after surgery
Secondary outcomes (1)
- measure
- Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
- timeFrame
- participants will be followed for 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.