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Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT01148966•University of Washington

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients may have clinically documented primary malignant glioma for which re-resection is clinically indicated; in this instance, previous pathology slides will be reviewed by University of Washington Medical Center (UWMC) Neuropathology prior to surgery; alternatively, patients may have imaging studies (magnetic resonance imaging \[MRI\] and /or computed tomography \[CT\] scans), which are highly indicative of a new malignant glioma, for which surgical resection is clinically warranted; the anticipated histology at resection should include: glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma (mixed glioma)
•Prior therapy is not a consideration in protocol entry; patients with recurrence of known malignant gliomas are eligible following UWMC neuropathology slide review
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
•Life expectancy is not a consideration for protocol entry
•Patients must have normal organ and marrow function as defined below:
•Leukocytes \>= 3,000/uL
•Absolute neutrophil count \>= 1,500/uL
•Platelets \>= 100,000/uL
•Total bilirubin within normal institutional limits
•Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
+3 more criteria

Exclusion Criteria

•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 ALA
•Personal or family history of porphyrias
•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
•Pregnant women are excluded from this study because ALA is of unknown teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued if the mother is treated with ALA

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

April 1, 2012

Last Updated

February 15, 2017

Enrollment

ACTUAL participants

Conditions

Adult Anaplastic AstrocytomaAdult Anaplastic OligodendrogliomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Mixed GliomaRecurrent Adult Brain Tumor

Interventions

aminolevulinic acid

DRUG

laboratory biomarker analysis

OTHER

therapeutic conventional surgery

PROCEDURE

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

NCT01894061

Adult Giant Cell GlioblastomaAdult Glioblastoma+2 more

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COMPLETEDPHASE2

Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

NCT01730950

Adult Giant Cell GlioblastomaAdult Glioblastoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors

Inclusion Criteria

Exclusion Criteria

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

Gossypol in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme