Photodynamic Therapy (PDT) for Poor Prognosis Recurrent/Refractory Malignant Brain Tumors - A Phase I Study
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerable dose (MTD) of Photofrin® in pediatric subjects
MTD is defined as the Photofrin® dose that precedes the dose level used with a subgroup of subjects that exhibits a greater than 33% DLT occurrence. DLT is defined as any of the following events with reasonable possibility to be attributable to the experimental intervention: Neurotoxicity: defined as a decline in neurological function manifest within 1 week of PDT and persistent to 4 weeks post-PDT. Adverse events of neurologic function of grade 4, or a level change from grade 1 to grade 3, within this period will constitute neurotoxicity for this study. The CTCAE V4.02 will be used. Photosensitivity: defined as a photosensitivity adverse event (CTCAE category dermatology/skin) of grade 4 occurring within the same period. Ocular sensitivity: Photofrin®-induced ocular sensitivity is defined as a photophobia adverse event (CTCAE category ocular/visual) of grade 4 within the same period. Any other toxicity of CTCAE grade 4 or higher within the same period.
One to four weeks from PDT
Yes
Harry T Whelan, MD
Principal Investigator
Medical College of Wisconsin
United States: Food and Drug Administration
163588-1
NCT01682746
March 2013
April 2021
Name | Location |
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Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53201 |