TheranosticTrials.org

Clinical Trial · NCT00874614

A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Overview

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.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 2

Contacts

Daniel Pryma, MD (PRINCIPAL_INVESTIGATOR)

Michael H Pampaloni, MD (PRINCIPAL_INVESTIGATOR)

Lale Kostakoglu, MD (PRINCIPAL_INVESTIGATOR)

Bennett Chin, MD (PRINCIPAL_INVESTIGATOR)

Joseph Dillon, MD (PRINCIPAL_INVESTIGATOR)

Camillo Jimenez, MD (PRINCIPAL_INVESTIGATOR)

Jeffrey Olsen, MD (PRINCIPAL_INVESTIGATOR)

Lilja Solnes, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00874614

Drug / Compound

iobenguane

Isotope(s):
Target(s):
  • NET
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Be on stable antihypertensive medication for pheochromocytoma-related hypertension for at least 30 days
  • Be ineligible for curative surgery for pheochromocytoma
  • Have at least one tumor site by CT or MR or iobenguane I 131 scan
  • Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates for chemotherapy or other curative therapies
  • 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.
  • 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.
  • Have an expected survival of at least 6 months
  • Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma

Exclusion

  • Karnofsky Performance Status is \< 60
  • Received external beam radiotherapy to \> 25% of bone marrow
  • 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
  • Received a therapeutic investigational compound and/or medical device/prior chemotherapy within 30 days before admission into this study
  • 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
  • Active chronic alcohol abuse, chronic liver disease or hepatitis
  • \<50% of FDG (if data are available) positive lesions are MIBG avid
  • 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.
  • Renal dysfunction/impairment
  • Subjects will be excluded if any of the following conditions are observed:
  • Known allergy to iobenguane that has required medical intervention
  • 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.
  • Pregnant or nursing females
  • Platelets \< 80,000/μL
  • Active CNS lesions by CT/MR scanning within 3 months of study entry
  • Diagnosed with AIDS or HIV-positive
  • 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.
  • Administered prior whole-body radiation therapy
  • 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
  • Receiving a medication which inhibits tumor uptake of iobenguane I 131