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- Title
Safety and Efficacy of 188-Rhenium-Labeled Antibody to Melanin in Patients with Metastatic Melanoma.
- Authors
Klein, M.; Lotem, M.; Peretz, T.; Zwas, S. T.; Mizrachi, S.; Liberman, Y.; Chisin, R.; Schachter, J.; Ron, I. G.; Iosilevsky, G.; Kennedy, J. A.; Revskaya, E.; de Kater, A. W.; Banaga, E.; Klutzaritz, V.; Friedmann, N.; Galun, E.; DeNardo, G. L.; DeNardo, S. J.; Casadevall, A.
- Abstract
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 188Re-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 188Re-6D2 were given while unlabeled antibody preload was escalated. In Phase Ib, the dose of 188Re-6D2 was escalated to 54 mCi. SPECT/CT revealed 188Re-6D2 uptake in melanoma metastases. The mean effective half-life of 188Re-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 188Re-6D2 was well tolerated, localized in melanoma metastases, and had antitumor activity, thus warranting its further investigation in patients with metastatic melanoma.
- Subjects
MELANOMA treatment; RHENIUM; IMMUNOGLOBULINS; MELANINS; MEDICATION safety; PHARMACOKINETICS; RADIATION dosimetry; THERAPEUTICS
- Publication
Journal of Skin Cancer, 2013, p1
- ISSN
2090-2905
- Publication type
Article
- DOI
10.1155/2013/828329