NCT02961491

Brief Summary

The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

First QC Date

November 8, 2016

Last Update Submit

January 28, 2019

Conditions

PheochromocytomaParaganglioma

Keywords

MIBGAzedraRare neuroendocrine tumorsIobenguane I 131Progenics

Interventions

Ultratrace Iobenguane I131DRUG

Subjects will receive a dosimetry dose of AZEDRA and will undergo 3 whole body scans. If the scans indicate tumor avidity for AZEDRA, the subjects will receive up to 2 therapeutic doses of AZEDRA each at 500 mCi (or 8 mCi/kg, for subjects weighing 62.5 kg or less) approximately 90 days apart.

Also known as: Azedra, MIBG

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to provide informed consent/assent and comply with protocol requirements
  • Documented diagnosis of either pheochromocytoma or paraganglioma that was confirmed by histology or other supportive data (e.g. abnormal MIBG diagnostic study or elevated tumor markers)
  • Ineligible for curative surgery for PPGL
  • Failed a prior therapy for PPGL or have no alternative indicated therapy available
  • Have definitive tumor avidity confirmed by the AZEDRA dosimetry dose
  • Life expectancy of at least 6 months per physician

You may not qualify if:

  • Pregnant or nursing females
  • Men or women of childbearing potential and unwilling to use a medically acceptable form of contraception from time of consent until 6 months following last therapeutic dose of AZEDRA
  • Active CNS lesions by CT/MRI within 3 months of informed consent
  • NYHA class IV heart failure, unstable angina pectoris or clinically significant cardiac arrhythmia that poses a risk of syncope or cardiac arrest
  • Prior systemic radiotherapy resulting in marrow toxicity within 3 months of first AZEDRA therapeutic dose
  • Prior iobenguane I 131 therapeutic exposure within 12 weeks of the first planned therapeutic dose
  • Prior administration of whole-body radiation therapy within 12 weeks of the first planned therapeutic dose
  • Prior external beam radiotherapy to \> 25% of bone marrow
  • Prior chemotherapy or investigational compound and/or device within 30 days of the dosimetry dose
  • Other active malignancy requiring additional treatment except for superficial cutaneous neoplasms
  • Karnofsky Performance Status \< 60
  • Clinically significant laboratory abnormalities prior to dosing as listed in the protocol (such as blood count abnormalities, liver enzyme abnormalities, and renal dysfunction)
  • Medical history of AIDS/HIV+
  • Active chronic alcohol abuse, chronic liver disease (not including liver metastases), hepatitis A, B, or C
  • Known allergy to iobenguane that has required medical intervention
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

PheochromocytomaParaganglioma

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsIodobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrocarbons, IodinatedHydrocarbons, Halogenated

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 11, 2016

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

US(3)