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

Phase 2
12 Years
Open (Enrolling)
Pheochromocytoma, Paraganglioma

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Trial Information

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

Azedra™ Ultratrace™ (Iobenguane I 131), commonly referred to as Ultratrace Iobenguane I 131,
is a very high specific activity form of iobenguane I 131, produced using Molecular
Insight's proprietary Ultratrace™ platform. Based on the well characterized cellular active
transport mechanism, the higher the specific activity of iobenguane I 131, the greater the
cellular uptake of radioactivity and hence greater tumor uptake.

During this study the subjects will receive two (2) Therapy Doses that are given three (3)
months apart. Prior to administration of the first Therapy Dose, subjects will be given an
Imaging Dose of Ultratrace Iobenguane I 131 and will undergo iobenguane I 131 scans to
evaluate tumor uptake and to measure normal organ distribution and allow for the calculation
of radiation dose to normal organs.

Screening procedures for eligibility will need to be done before imaging or therapeutic
doses of Iobenguane I 131 are administered.

Hospitalization is required for approximately one (1) week after each of the two (2)
Therapeutic Doses. Frequent follow up is necessary for the first year and some of the
follow up visits may be done by a visiting health care professional in the subjects' homes.
Subjects will be followed in the treatment study for one (1) year and for an additional four
(4) years in long-term follow up.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of study subjects with a reduction (including discontinuation) of all antihypertensive medication by at least 50% for at least six months or two cycles Ultratrace Iobenguane I 131.

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

Edward Coleman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Pheochromocytoma
  • Paraganglioma
  • radiotherapy
  • MIBG
  • Azedra
  • neuroendocrine tumors
  • paraganglioma
  • pheochromocytoma
  • Iobenguane I 131
  • Paraganglioma
  • Pheochromocytoma



Johns Hopkins UniversityBaltimore, Maryland  21205
University of IowaIowa City, Iowa  52242
MD Anderson Cancer CenterHouston, Texas  77030-4096
Mount Sinai School of MedicineNew York, New York  10029
Rhode Island HospitalProvidence, Rhode Island  02903
University of California-San FranciscoSan Francisco, California  94143
Duke University Medical CenterDurham, North Carolina  27710
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University Of Miami Miller School Of MedicineMiami, Florida  33010
Louisana State University Health Sciences CenterShreveport, Louisiana  71103
Washington University School of Medicine, Alvin J. Siteman Cancer CenterSt. Louis, Missouri  63110