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

Inclusion Criteria:

- Have a diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma by
histological confirmation OR plasma-free metanephrines and 24-hour urine test for
catecholamines/ metanephrines

- Disease is metastatic or has recurred following surgery

- At least one measurable lesion seen by computed tomography (CT) or magnetic resonance
(MR) scan performed within 4 weeks prior to the first dose of study drug

- At least one known tumor site is also seen on Ultratrace iobenguane I 131 scan

- Provide written informed consent and are willing to comply with protocol requirements

- Are at least 18 years of age

- If female, then not of childbearing potential as documented by history (e.g., tubal
ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses

- If female of childbearing potential, has a negative serum b-HCG pregnancy test within
48 hours prior to receiving iobenguane I 131

- Females who agree not to become pregnant and males who agree not to father a child
during the 1 year period following the therapeutic dose of Ultratrace iobenguane I
131. Both females and males must use an acceptable method of birth control during
the first year following the therapeutic dose of Ultratrace iobenguane I 131.

Exclusion Criteria:

- Females who are nursing

- Active CNS lesions by CT/MR scanning within 3 months of study entry

- New York Heart Association class III-IV heart failure

- Received any previous systemic radiotherapy within 6 months of study entry

- Administered prior whole-body radiation therapy

- Received external beam radiotherapy to greater than 25 percent of bone marrow

- Administered prior chemotherapy within 30 days of study entry

- Karnofsky performance status is less than 60

- Platelets are less than 100,000/uL

- Absolute neutrophil count (ANC) is less than 1,500/uL

- Serum creatinine is greater than 1.5 mg/dL

- Total bilirubin is greater than 1.5 times the upper limit of normal

- AST/SGOT or ALT/SGPT is greater than 2.5 times the upper limit of normal

- Has received a therapeutic investigational compound and/or medical device within 30
days before admission into this study

- Has any medical condition or other circumstances which would significantly decrease
the chances of obtaining reliable data, achieving study objectives, or completing the
study and/or post dose follow-up examinations

- Is determined by the Investigator that the patient is clinically unsuitable for the
study.

- Has received a medication which inhibits uptake of iobenguane I 131:

- phenothiazines or decongestants within 2 weeks prior to enrollment; or,

- a tricyclic antidepressant within 6 weeks prior to enrollment.