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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00946 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (photodynamic therapy) | Experimental | Patients receive aminolevulinic acid PO 4 hours before undergoing surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aminolevulinic acid | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of a safe dose for oral ALA administration | 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. | For 30 days post-aminolevulinic acid dose |
| Determination of which of 3 ALA doses provide optimal discrimination between normal and malignant tissue intraoperatively | 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. | During surgery and from samples collected during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of time-to-progression (TTP) and survival to that in comparable cases performed without the aid of ALA | At week 5 and then every 8-12 weeks for 27 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Silbergeld | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| laboratory biomarker analysis | Other | Correlative studies |
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| therapeutic conventional surgery | Procedure | Standard brain tumor surgery with intra-operative frameless MRI stereotactic guidance and intra-operative ultrasound guidance |
|
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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