The overall goal of project #2 is to improve the survival of patients with malignant primary brain tumors by the use of Photofrin-PDT or by the use of combined fluorescence-guided tumor resection [FGR] and ALA-mediated PDT. Since malignant primary brain tumors rarely metastasize, local tumor control should result in prolongation of survival and a delayed recurrence. Two clinical trials of Photofrin-PDT have been undertaken. Clinical trial #1 is to determine in a randomized two arm clinical study whether the addition of Photofrin-PDT to surgical tumor resection, post-operative """"""""adiation and chemotherapy delays recurrence and increases survival in patients with newly-diagnosed malignant astrocytic tumors. Consented patients were randomized to a no-PDT control group and or to a high light dose [120 J/cm2] PDT group. This trial has now been closed and detailed analysis is in progress. Clinical trial #2 is to determine whether high light dose [120 J/cm2] Photofrin-PDT will delay recurrence and increase survival in comparison to low light dose Photofrin-PDT [40 J/cm2] in patients with recurrent malignant astrocytic tumors. This trial is accruing patients. There is growing evidence that survival is improved by surgically reducing the amount of residual tumor. FGR using ALA [a precursor of protoporphyrin IX, which has a highly selective tumor fluorescence and PDT effect] as the sensitizer is being assessed in European trials using subjective and qualitative intra-operative assessments. In clincical trial #3 we will determine the optimal dose and time of administration of ALA using a quanititative fluorescence detection camera system.
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