Our study on subcutaneously transplanted glioma C6, most pronounced antitumor effect with the maximal (100%) tumor necrosis was achieved in 2.5 h after intravenous administration of photolon with ultrasonic exposure at a frequency of 0.88 MHz and pulse intensity of 0.7 W/cm [19,20].Obtained in the experiment data formed the basis for further study of the efficacy and safety of this method in the clinic.The first stage of the treatment was total/subtotal TR followed by intravenous administration of photolon; then the tumor bed was consequtively exposed to ultrasound (1.04 MHz; 1 W/cm) 0.5 h after the start of photolon infusion.Within 4 weeks after discharge from hospital all patients underwent chemotherapy.The toxicity of anticancer therapies was evaluated on the basis of frequency and severity of adverse reactions accounted in accordance with CTCAE (Version 4.0).
Photolon was injected intravenously shortly before TR that was followed by i SDT and i PDT.
The median OS of died patients from first diagnosis was 23.9 months in i SPDT and 12.1 months in control group, respective (p=0.004).
The post-i SPDT median survival was 8.2 month, while in the control group (without i SPDT) it was 5.8 month (p=0.012).
The criterium of treatment effeicacy was median overall survival (OS) of the animals.
The clinical Phase I study comprised 15 patients with recurrent malignant gliomas.