Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors
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|ClinicalTrials.gov Identifier: NCT01148966|
Recruitment Status : Terminated
First Posted : June 23, 2010
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Recurrent Adult Brain Tumor||Drug: aminolevulinic acid Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||April 2012|
Experimental: Treatment (photodynamic therapy)
Patients receive aminolevulinic acid PO 4 hours before undergoing surgery.
Drug: aminolevulinic acid
Other: laboratory biomarker analysis
Procedure: therapeutic conventional surgery
Standard brain tumor surgery with intra-operative frameless MRI stereotactic guidance and intra-operative ultrasound guidance
- Establishment of a safe dose for oral ALA administration [ Time Frame: For 30 days post-aminolevulinic acid dose ]Using National Cancer Institute (NCI) Common Toxicity Criteria to quantify toxicity following ALA administration. We will use descriptive statistics to analyze the safety data, based on NCI toxicity criteria.
- Determination of which of 3 ALA doses provide optimal discrimination between normal and malignant tissue intraoperatively [ Time Frame: During surgery and from samples collected during surgery ]The results from three methods will be used collectively to determine whether or not it is prudent, safe and justified to proceed with 12 more patients using the highest dose tolerated without undue toxicity. The results from these three methods, both surgical fluorescence rating and neuropathologist ratings of fluorescence and presence, or absence, of tumor will be compared using a correlation coefficient.
- Comparison of time-to-progression (TTP) and survival to that in comparable cases performed without the aid of ALA [ Time Frame: At week 5 and then every 8-12 weeks for 27 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148966
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Daniel Silbergeld||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|