Photodynamic Therapy (PDT) for Recurrent Pediatric Brain Tumors
Condition: Brain Tumor, Recurrent
MeSH terms: Brain Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this proposal is to evaluate a new Photodynamic Therapy (PDT) modification which
      could revolutionize the treatment of brain tumors in children and adults. There are currently
      few cases published involving the use of PDT in infratentorial (in the posterior fossa) brain
      tumors in general and specifically those occurring in children. The investigators propose to
      test a technique, for the first time in the U.S., that demonstrated in Australian adult
      glioblastoma patients dramatic long-term, survival rates of 57% (anaplastic astrocytoma) and
      37% (glioblastoma multiforme). These results are unprecedented in any other treatment
      protocol.

      Photodynamic therapy (PDT) is a paradigm shift in the treatment of tumors from the
      traditional resection and systemic chemotherapy methods. The principle behind photodynamic
      therapy is light-mediated activation of a photosensitizer that is selectively accumulated in
      the target tissue, causing tumor cell destruction through singlet oxygen production.
      Therefore, the photosensitizer is considered to be the first critical element in PDT
      procedures, and the activation procedure is the second step. The methodology used in this
      proposal utilizes more intensive laser light and larger Photofrin photosensitizer doses than
      prior PDT protocols in the U.S. for brain tumor patients. The PDT will consist of
      photoillumination at 630 nm beginning at the center of the tumor resection cavity, and
      delivering a total energy of 240 J cm-2. The investigators feel that the light should
      penetrate far enough into the tissue to reach migrating tumor cells, and destroy these cells
      without harming the healthy cells in which they are dispersed.

      The investigators will be testing the hypothesis that pediatric subjects with
      progressive/recurrent malignant brain tumors undergoing PDT with increased doses of
      Photofrin® and light energy than were used in our previous clinical study will show better
      progression free survival (PFS) and overall survival (OS) outcomes. PDT will also be
      effective against infratentorial tumors. The specific aims include determining the maximum
      tolerable dose (MTD) of Photofrin in children and looking for preliminary effectiveness
      trends.
    


Intervention name(s): Photofrin (porfimer sodium) & photodynamic therapy.
Intervention type(s): Drug
Intervention description(s): Intravenous (IV) Photofrin
This is a dose escalation study. Patients will receive Photofrin via an IV infusion approximately 24 hours prior to their tumor resection surgery and Photodynamic Therapy (PDT). Patients will be light sensitive immediately upon receiving the Photofrin and must observe photosensitivity & light precautions for a minimum of 30 days after the infusion.
Photodynamic Therapy (PDT)
After tumor resection, an optical fiber will be placed in the approximate center of the surgical cavity. Intralipid will be infused into the open tumor cavity while PDT is performed. The Intralipid will diffuse the light and ensure uniform delivery. Photoactivation of Photofrin is controlled by the total light dose delivered over the treatment time.
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain Tumor; Photodynamic Therapy; Photochemotherapy; Astrocytoma; Pilocytic Astrocytoma; Low grade Astrocytoma; Anaplastic Astrocytoma; Glioblastoma; GBM; Chordoma; Germinoma; Germ Cell Tumor; Non-germinaoma; CNS Lymphoma; Craniopharyngioma; Brain Stem Glioma; Ependymoma; Mixed Glioma; Optic Nerve Glioma; Subependymoma; Medulloblastoma; Meningioma; Metastatic Brain Tumors; Oligodendroglioma; Pituitary Tumors; Primitive Neuroectodermal; PNET; Desmoplastic Neuroepithelial Tumor; DNET