Children’s Hospital, MCW launch clinical trial for treatment of childhood brain tumors
April 02, 2013 College News - Children and adolescents with recurrent or progressive brain tumors will have an opportunity to participate in a new Phase 1 clinical trial conducted by Children’s Hospital of Wisconsin and the Medical College of Wisconsin investigating the safety of a novel brain cancer treatment.
The survival of pediatric patients with recurrent brain tumors is measured in months, with few long-term survivors. New therapies for children with brain tumors are needed. Photodynamic therapy (PDT) is a promising treatment for patients with recurrent, malignant brain tumors. PDT is a two-step cancer treatment process. A photosensitizing drug called PHOTOFRIN® is injected into the blood stream of patients where it accumulates in cancer cells in the brain. Immediately after surgical removal of the tumor, PHOTOFRIN® is activated with laser light killing any remaining cancer cells in the nearby brain. A previous clinical trial using PDT for the treatment of adults with recurrent, malignant brain tumors demonstrated long-term survival in 40%-50% of patients.
Harry T. Whelan, MD, the Bleser Professor of Neurology and Pediatrics and Hyperbaric Medicine at Children’s Hospital of Wisconsin, and Professor of Neurology at the Medical College of Wisconsin, is the lead investigator for the study. “We believe the findings from prior studies of PDT in adults warrants application in pediatric patients with recurrent/refractory, high-grade brain tumors. Children’s Hospital of Wisconsin (CHW) is one of the few centers in the country with experience utilizing PDT technology for the treatment of brain tumors ii. As a result we are uniquely poised to apply PDT treatment in pediatric patients.” Dr. Whelan‘s clinical research team has partnered with Pinnacle Biologics, Inc. who will provide PHOTOFRIN®, the laser and additional resources and expertise to make the study possible.
This is a Phase 1 limited dose-escalation study of PHOTOFRIN® in pediatric and adolescent patients with recurrent or refractory, malignant brain tumors. The primary objective of this study is to identify a maximum tolerated dose (MTD) and to characterize the side-effect profile of PHOTOFRIN® in children with recurrent brain tumors.
Eligible patients will have injection of PHOTOFRIN® followed by surgical resection of the tumor 24 hours later. Activation of PHOTOFRIN® in the tumor bed will be performed using an intra-operative laser. Patients will receive standard post-operative care and will be closely monitored at CHW during the first month for side effects associated with PHOTOFRIN® activation. Patients will then return to their referring facilities and receive any additional therapy for treatment of their cancer. Long-term study monitoring will be performed through referring facilities.
More information about the clinical trial can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01682746