5-ALA in Recurrent Glioma

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria

• Presumed recurrent glioma

• Age > 18 years

• Normal bone marrow function (WBC > 3000, Platelets > 100,000)

Exclusion Criteria

• Pregnancy

• History of photosensitivity, porphyria, or exfoliative dermatitis

• Hepatic dysfunction in the last 12 months [defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin > 2.5 x normal]

• Serum creatinine > 180 µmol/L

• Estimated Glomerular Filtration Rate (eGFR)< 60 ml/min/1.73m2

• Inability to undergo MRI with contrast