Trials / Terminated
TerminatedNCT01148966
Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors
A Phase 1 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial is studying the side effects and best dose of aminolevulinic acid during surgery in treating patients with malignant brain tumors. Aminolevulinic acid becomes active when it is exposed to a certain kind of light and may help doctors find and remove tumor cells during surgery
Detailed description
PRIMARY OBJECTIVES I. Establish a safe dose for oral ALA administration. SECONDARY OBJECTIVES I. Determine which of 3 ALA (aminolevulinic acid) doses (10, 20 or 30 mg/kg) provide optimal discrimination between normal and malignant tissue intraoperatively. II. Determine whether or not the use of ALA (compared to comparable cases performed without the aid of ALA) leads to a higher rate of gross total resection, as determined by postoperative MRI scanning within 48 hour of surgery completion. III. Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA. OUTLINE: This is a phase I, dose-escalation study Patients receive aminolevulinic acid orally (PO) 4 hours before undergoing surgery. After completion of study treatment, patients are followed up at week 5 and then every 8-12 weeks for 27 months.
Conditions
- Adult Anaplastic Astrocytoma
- Adult Anaplastic Oligodendroglioma
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Adult Mixed Glioma
- Recurrent Adult Brain Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aminolevulinic acid | Given PO |
| OTHER | laboratory biomarker analysis | Correlative studies |
| PROCEDURE | therapeutic conventional surgery | Standard brain tumor surgery with intra-operative frameless MRI stereotactic guidance and intra-operative ultrasound guidance |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2012-04-01
- First posted
- 2010-06-23
- Last updated
- 2017-02-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01148966. Inclusion in this directory is not an endorsement.