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Clinical Trials
Interim Analysis of Toxicity and Response in Phase 1 Trial of Systemic Targeted Alpha Therapy for Metastatic Melanoma
Chand Raja, Peter Graham, Syed Rizvi, Emma Song, Helen Goldsmith, John Thompson, Anja Bosserhoff, Alfred Morgenstern, Christos Apostolidis, John Kearsley, Ralph Reisfeld and Barry J Allen
volume 6 | issue 6
June 2007We now provide open access to journal articles published online for one year or more. This article may be downloaded at the following link:
Download PDFIf the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.
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 alpha-immunoconjugate 213Bi-cDTPA-9.2.27 mAb (AIC). Tools used to investigate the effects were physical examination; imaging of tumours; pathology; GFR; CT and changes in tumour marker. Responses were assessed using RECIST criteria.
Results and Discussion. 22 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 tumour on mandible and reduction in lung lesions. Overall 30% showed progressive disease.
The tumour marker melanoma inhibitory activity protein (MIA) showed reductions over 8 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 to be a safe and effective therapeutic approach for metastatic melanoma.
We now provide open access to journal articles published online for one year or more. This article may be downloaded at the following link:
Download PDFIf the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.