Photofrin - Photodynamic therapy for malignant brain tumors

In a phase II trial we treated more than 100 patients with malignant brain tumors with 2-mg/kg Photofrin i.v. and intraoperative cavitary PDT. We concluded that PDT was safe in patients with newly diagnosed or recurrent supratentorial malignant gliomas. Regression analysis showed that pathology, performance grade and fight dose were significantly related to survival time. We identified a prolongation of survival in selected patients when an adequate fight dose was used. The surgical mortality rate was less than 3%. We have initiated two randomized prospective trials - the first, to determine if the addition of PDT to standard therapy [surgery, radiation and/or chemotherapy] prolongs the survival of patients with newly diagnosed malignant astrocytic tumors; and the second, to determine whether high light dose PDT [120 J/cm(2)] is superior to low light dose PDT [40 J/cm(2)] in patients with recurrent malignant astrocytic tumors. In the first 20 months of these clinical studies, 90 patients have been recruited. There were 52 in the recurrent study and 37 in the newly diagnosed study. 64% of the tumors were glioblastoma and 23% malignant astrocytoma or malignant mixed glioma. In the trial of newly diagnosed tumors 17 were randomized to surgery with a mean age of 58 ! 2.9 [sem] and 20 to surgery plus PDT with a mean age of 54 ! 2.5. In recurrent glioma trial 26 were randomized to low light dose PDT [mean age 48.1 ! 2.7] and 26 to high light dose [age 52 ! 2.7]. An update of our phase 2 data and a description of brain tumor PDT techniques is presented below. The clinical studies are supported in part by grant CA 43892 awarded by DHHS/NIH/NCl.