A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Inclusion Criteria:

- Be at least 12 years of age

- Have a documented (medical record) diagnosis of either pheochromocytoma or
paraganglioma with histological confirmation

- Be ineligible for curative surgery for pheochromocytoma

- Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates
for chemotherapy or other curative therapies

- Be on stable antihypertensive medication for pheochromocytoma-related hypertension
for at least 30 days

- Have at least one tumor site by CT or MR or iobenguane I 131 scan

- Have an expected survival of at least 6 months

- Subjects must agree to use an acceptable form of birth control (abstinence, IUD, oral
contraception, barrier and spermicide or hormonal implant) during this study and for
6 months following Therapeutic Doses of Ultratrace Iobenguane I 131.

- Male subjects must agree not to father a child during the period beginning
immediately after administration of the first Therapeutic Dose of Ultratrace
Iobenguane I 131 during the study and ending six months after administration of the
last Therapeutic Dose of Ultratrace Iobenguane I 131.

Exclusion Criteria:

Subjects will be excluded if any of the following conditions are observed:

- <50% of FDG (if data are available) positive lesions are MIBG avid

- Pregnant or nursing females

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

- New York Heart Association class IV heart failure, symptomatic congestive heart
failure [New York Heart Association class IV with another medical disorder], unstable
angina pectoris, cardiac arrhythmia

- Received any previous systemic radiotherapy resulting in marrow toxicity within 3
months of study entry or have active malignancy (other than
pheochromocytoma/paraganglioma) requiring additional treatment during the active
phase or follow up period of the Ultratrace iobenguane I 131 trial.

- Administered prior whole-body radiation therapy

- Received external beam radiotherapy to > 25% of bone marrow

- Administered prior chemotherapy within 30 days or have active malignancy (other than
pheochromocytoma/ paraganglioma) requiring additional treatment during the active
phase or follow up period of the Ultratrace iobenguane I 131 trial.

- Karnofsky Performance Status is < 60

- Platelets < 80,000/μL

- Absolute neutrophil count (ANC) < 1,200/μL, Total bilirubin > 1.5 times the upper
limit of normal, AST/SGOT or ALT/SGPT > 2.5 times the upper limit of normal

- Diagnosed with AIDS or HIV-positive

- Active chronic alcohol abuse, chronic liver disease or hepatitis

- Renal dysfunction/impairment

- Known allergy to iobenguane that has required medical intervention

- Received a therapeutic investigational compound and/or medical device/prior
chemotherapy within 30 days before admission into this study

- Receiving a medication which inhibits tumor uptake of iobenguane I 131

- Any medical condition or other circumstances (i.e., uncontrolled current illness
including but not limited to, ongoing or active infection or psychiatric
illness/social situations that would limit compliance with the study requirements.

- Any other condition, that in the opinion of the investigator, may compromise the
safety or compliance of the subject or would preclude the subject from successful
completion of the study