Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01575275 : Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent
GBM or suspected GBM (in patient with pathologically diagnosed prior World Health
Organization [WHO] grade II or III tumor) in a patient undergoing a
clinically-indicated surgery.

- Age >= 18 years of age.

- 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:

- 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 pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits; OR

- Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above
institutional normal

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document
or have a parent or guardian with the ability to understand and the willingness to
sign a written informed consent

Exclusion Criteria:

- Prior therapy is not an exclusion criterion

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to aminolevulinic acid (ALA)

- Current treatment with hypericin (or an extract) or other photosensitizing agents

- Personal or immediate family (parents, siblings, children) 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; breastfeeding should be discontinued if
the mother is treated with ALA
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01575275      |      Link to official Clinicaltrials.gov listing
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