TheranosticTrials.org

Clinical Trial · NCT00458952

Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Overview

The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 1/2

Contacts

Molecular Insight Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT00458952

Drug / Compound

iobenguane

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

Eligibility

Inclusion

  • If female of childbearing potential, has a negative serum b-HCG pregnancy test within 48 hours prior to receiving iobenguane I 131
  • At least one known tumor site is also seen on Ultratrace iobenguane I 131 scan
  • 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.
  • 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
  • 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
  • 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
  • Disease is metastatic or has recurred following surgery

Exclusion

  • Active CNS lesions by CT/MR scanning within 3 months of study entry
  • Total bilirubin is greater than 1.5 times the upper limit of normal
  • Karnofsky performance status is less than 60
  • Administered prior whole-body radiation therapy
  • Serum creatinine is greater than 1.5 mg/dL
  • Is determined by the Investigator that the patient is clinically unsuitable for the study.
  • Administered prior chemotherapy within 30 days of study entry
  • Received any previous systemic radiotherapy within 6 months of study entry
  • Has received a therapeutic investigational compound and/or medical device within 30 days before admission into this study
  • Absolute neutrophil count (ANC) is less than 1,500/uL
  • Received external beam radiotherapy to greater than 25 percent of bone marrow
  • phenothiazines or decongestants within 2 weeks prior to enrollment; or,
  • 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
  • AST/SGOT or ALT/SGPT is greater than 2.5 times the upper limit of normal
  • a tricyclic antidepressant within 6 weeks prior to enrollment.
  • Platelets are less than 100,000/uL
  • Females who are nursing
  • New York Heart Association class III-IV heart failure
  • Has received a medication which inhibits uptake of iobenguane I 131: