Safety and efficacy of 188-rhenium-labeled antibody to melanin in patients with metastatic melanoma

M Klein, M Lotem, T Peretz, S T Zwas, S Mizrachi, Y Liberman, R Chisin, J Schachter, I G Ron, G Iosilevsky, J A Kennedy, E Revskaya, A W de Kater, E Banaga, V Klutzaritz, N Friedmann, E Galun, G L Denardo, S J Denardo, A CasadevallE Dadachova, G B Thornton

Research output: Contribution to journalArticlepeer-review


There is a need for effective "broad spectrum" therapies for metastatic melanoma which would be suitable for all patients. The objectives of Phase Ia/Ib studies were to evaluate the safety, pharmacokinetics, dosimetry, and antitumor activity of (188)Re-6D2, a 188-Rhenium-labeled antibody to melanin. Stage IIIC/IV metastatic melanoma (MM) patients who failed standard therapies were enrolled in both studies. In Phase Ia, 10 mCi (188)Re-6D2 were given while unlabeled antibody preload was escalated. In Phase Ib, the dose of (188)Re-6D2 was escalated to 54 mCi. SPECT/CT revealed (188)Re-6D2 uptake in melanoma metastases. The mean effective half-life of (188)Re-6D2 was 12.4 h. Transient HAMA was observed in 9 patients. Six patients met the RECIST criteria for stable disease at 6 weeks. Two patients had durable disease stabilization for 14 weeks and one for 22 weeks. Median overall survival was 13 months with no dose-limiting toxicities. The data demonstrate that (188)Re-6D2 was well tolerated, localized in melanoma metastases, and had antitumor activity, thus warranting its further investigation in patients with metastatic melanoma.

Original languageEnglish
Pages (from-to)828329
JournalJournal of Skin Cancer
StatePublished - 2013


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