Interim analysis of oxicity and response in phase 1 trial of systemic targeted alpha therapy for metastatic melanoma

Purpose: The aim is to assess toxicity and response of systemic alpha therapy for metastatic melanoma. Experimental design: This is an open-labelled Phase 1 dose escalation study to establish the effective dose of the a-immunoconjugate Bi-213-cDTPA-9.2.27 mAb (AIC). Tool: used to investigate the effects were physical examination; imaging of tumors pathology GFR; CT and changes in tumor marker. Responses were assessed using RECIST criteria. Results and discussion: Twenty-two patients with stage IV melanoma/in-transit metastasis were treated with activities of 55-947 MBq. Using RECIST criteria 50% showed stable disease and 14% showed partial response. One patient (6%) showed near complete response and was retreated because of an excellent response to the initial treatment, Another patient showed response in his tumor on mandible and reduction in lung lesions Overall 30% showed progressive disease. The tumor marker melanoma inhibitory activity protein (MIA) showed reductions over eight weeks in most of the patients. The disparity of dose with responders is discussed No toxicity was observed over the range of administered activities. Conclusion: Observation of responses without any toxicity indicates that targeted alpha therapy has the potential metastatic melanoma.