Clinical Trial Details
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NCT01128218 : A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patients must have clinically documented primary brain tumor for which resection is
clinically indicated.

- Age ? 18 years. Because no dosing or adverse event data are currently available on
the use of 5-ALA in patients <18 years of age, children are excluded from this study
but will be eligible for future pediatric phase 1 single-agent trials

- ECOG performance status <2 (Karnofsky >60%)

- Normal organ and marrow function as defined below:

- Leukocytes > 3,000/mcL

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- 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

- Agreement by women of child-bearing potential and men to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agents at the time of entry
into the study

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to 5-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 5-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 5-ALA,
breastfeeding should be discontinued if the mother is treated with 5-ALA
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