Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas

PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

December 19, 2017

Study Completion Date

December 19, 2017

Conditions
Brain Tumor, Recurrent
Interventions
DRUG

Photofrin photodynamic therapy.

"The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:~Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence. After PDT, the Intralipid solution will be removed and the wound will be closed. The subject will be sent to the intensive care area for recovery."

Trial Locations (1)

53226

Medical College of Wisconsin/ Froedtert Hospital, Milwaukee

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pinnacle Biologics Inc.

INDUSTRY

lead

Harry T Whelan, MD

OTHER

NCT01966809 - Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas | Biotech Hunter | Biotech Hunter