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Objective:This phase I clinical trial was designed to determine the maximum tolerated dose (MTD) and tumor response using CLIPT for cutaneous recurrence of breast and dermal malignancies.
Design:The study design entailed sequential cohorts of 6 patients to be treated at increasing laser intensity, starting at 100 j/cm2. Dose limiting toxicity (DLT) was defined as full thickness necrosis. The MTD was defined as the highest dose level at which < 33% of patients experienced the DLT. Tumor response and quality of life data points were evaluated at post-treatment days1,7,30, 60,and90.
Setting:The study intervention was administered in an in-patient setting at an urban university hospital.
Patients: Eleven patients were enrolled that had failed 30Gy of radiation therapy: 9 with recurrent breast cancer and 2 with recurrent dermal cancers. Patients with prior photosensitivity were excluded.
Interventions:Patients were injected with Photofrin at a dose of 0.8mg/kg body weight and underwent 24 hours of continuous photodynamic therapy.
Main Outcome Measures: MTD, histologic and clinical tumor response were primary outcome measures. Quality of life data served as a secondary outcome.
Results: Two patients were treated at 100 j/cm2 and suffered DLT. The next cohort was dose reduced and treated at 50 j/cm2. One patient suffered DLT, establishing the MTD at 50 j/cm2. 73% of patients demonstrated a complete or partial clinical response. Two patients had regression of tumor nodules distant from the treatment field. Quality of life measures, particularly bleeding and pain, were improved. Of available assay results, 100% demonstrated a pathologic response.
Conclusions:The MTD of CLIPT was established at 50 j/cm2. CLIPT is a highly effective therapeutic modality in the treatment of dermal recurrence of both breast and cutaneous malignancies.