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Phase 1 Study Of High-Specific-Activity I-131 Mibg For Metastatic And/Or Recurrent Pheochromocytoma Or Paraganglioma, Richard B. Noto, Daniel A. Pryma, Jessica Jensen, Tess Lin, Nancy Stambler, Thomas Strack, Vivien Wong, Stanley J. Goldsmith
Phase 1 Study Of High-Specific-Activity I-131 Mibg For Metastatic And/Or Recurrent Pheochromocytoma Or Paraganglioma, Richard B. Noto, Daniel A. Pryma, Jessica Jensen, Tess Lin, Nancy Stambler, Thomas Strack, Vivien Wong, Stanley J. Goldsmith
NYMC Faculty Publications
Context: No therapies are approved for the treatment of metastatic and/or recurrent pheochromocytoma or paraganglioma (PPGL) in the United States. Objective: To determine the maximum tolerated dose (MTD) of high-specific-activity I-131 meta-iodobenzylguanidine (MIBG) for the treatment of metastatic and/or recurrent PPGL. Design: Phase 1, dose-escalating study to determine the MTD via a standard 3 + 3 design, escalating by 37 MBq/kg starting at 222 MBq/kg. Setting: Three centers. Patients: Twenty-one patients were eligible, received study drug, and were evaluable for MTD, response, and toxicity. Intervention: Open-label use of high-specific-activity I-131 MIBG therapy. Main Outcome Measures: Dose-limiting toxicities, adverse events, radiation …