A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Condition: Pheochromocytoma; Paraganglioma
MeSH terms: Pheochromocytoma; Paraganglioma
Intervention: Ultratrace® Iobenguane I131
Intervention description: Each subject will be administered 3 mCi to 6 mCi Ultratrace® Iobenguane I 131, referred to as the Imaging Dose, to confirm that subject meets radiological entry criteria and to establish dosimetry. All subjects meeting entry criteria will then receive the investigational product referred to as the Therapeutic Dose (500 mCi or 8 mCi/kg if the subject weighs 62.5 kg or less) of Ultratrace Iobenguane I 131, followed by imaging at 7 days post infusion or upon discharge from isolation. The Therapeutic Doses will be adjusted equally if warranted by results of the dosimetry evaluation. At least 3 months later, subjects will receive the second Therapeutic Dose.
Intervention MeSH terms: 3-Iodobenzylguanidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: radiotherapy; MIBG; Azedra; neuroendocrine tumors; Iobenguane I 131; progenics

Summary:

      This clinical trial is designed to evaluate the effectiveness and collect additional safety
      information on AZEDRA® (iobenguane I 131) for the treatment of metastatic or
      relapsed/refractory (to other treatment) or unresectable pheochromocytoma or paraganglioma.

      The purpose of this trial is to test the use of AZEDRA® as a treatment for pheochromocytoma
      and paraganglioma, a rare disease. This Phase II study will help determine primarily if using
      the drug reduces the amount of blood pressure medication being taken as a result of the
      cancer 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 therapeutic doses given approximately 3 months apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 12 years of age

          -  Have a documented (medical record) diagnosis of either pheochromocytoma or
             paraganglioma

          -  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