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Paragangliomas 1

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Iodine

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Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD. The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT). An additional 3 patients are to be treated at the MTD, for a total of 6.

Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose

Ultratrace Iobenguane (MIBG) I 131

Molecular Insight Pharmaceuticals

The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the patient received one therapeutic dose. In the phase 1 portion, the study employed a 3 + 3 dose escalation design. Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). Following discussions with the Food and Drug Administration (FDA) that occurred during the dose escalation stage of the study, the protocol was amended to conclude the trial upon the identification of the MTD. The Phase 2 safety/ efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B, with Special Protocol Assessment Agreement with the FDA in March 2009.

Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

A Phase I Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.

Molecular Insight Pharmaceuticals, Inc.

Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.

Ultratrace Iobenguane I 131

7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131

=< 500 mCi Ultratrace Iobenguane I 131

14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131

>500 mCi

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Senior Director, Clinical Science Communications

24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.

MTD of Ultratrace Iobenguane I 131

Overall Study

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