Neuroendocrine tumor patients with malignant pheochromocytoma or paraganglioma are being sought for a multi-center clinical trial conducted by Molecular Insight Pharmaceuticals, Inc. In the New York area, one of the clinical trial sites is the Mount Sinai School of Medicine. Dr. Richard R.P. Warner, Medical Director of the Carcinoid Cancer Foundation, Professor of Medicine at Mount Sinai School of Medicine, and one of the country’s leading carcinoid cancer and neuroendocrine tumor specialists, is a co-investigator on the clinical trial.
The purpose of the clinical trial, which is evaluating Ultratrace lobenuane I 131 (also known as AzedraTM), is to determine if the drug reduces the amount of blood pressure medication being taken as a result of these rare cancers and secondarily, to determine such things as the “effectiveness of the study drug in treating the cancer, additional safety measures and to assess if the drug helps the quality of life and use of pain medication. All subjects will receive an imaging dose with scans followed by two therapy doses that are given 3 months apart.” Ultratrace lobenuane I 131 is a form of I 131 MIBG but with higher specific activity.
The primary objective of this Phase II study, expected to enroll 75 patients ages 12 and older, is to achieve a reduction and/or discontinuation of all blood pressure medications by at least 50% for a minimum of six months. Patients will be evaluated for the effectiveness of the medication and safety during a 12-month period, then for survival for an additional 4 years.
Pheochromocytoma is a tumor of the adrenal gland that causes it to produce too much adrenaline. Pheochromocytomas are usually benign (noncancerous), but can also present as or develop into a malignancy. They can cause dangerously high blood pressure and other symptoms, including pounding headaches, heart palpitations, flushing of the face, nausea, and vomiting. Paragangliomas are rare neuroendocrine tumors that may develop at various body sites (including the head, neck, thorax and abdomen). About 97% are benign and cured by surgical removal; the remaining 3% are malignant because they are able to produce distant metastases.