Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

• ClinicalTrials.gov Identifier: NCT02961491
• Expanded Access Status: Approved for marketing
• First Posted: November 11, 2016
• Last Update Posted: January 30, 2019
• Sponsor: Molecular Insight Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Molecular Insight Pharmaceuticals, Inc.

Study Description

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).

Condition or disease	Intervention/treatment
Pheochromocytoma; Paraganglioma	Drug: Ultratrace Iobenguane I131

Detailed Description:

MIP-IB12B, the pivotal phase 2 study evaluating efficacy and safety of AZEDRA in patients with malignant relapsed/refractory PPGL, has completed its anticipated enrollment. The purpose of this sub-study, MIP-IB12B-EAP, is to provide expanded access to AZEDRA for newly enrolled subjects with iobenguane-avid metastatic and/or recurrent PPGL and to collect additional safety data.

Study Design

• Study Type: Expanded Access

See clinical trials of the intervention/treatment in this expanded access record.

• Official Title: Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B

Interventions

Intervention Details:

• Drug: Ultratrace Iobenguane I131
  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.
  Other Names:

  • Azedra
  • MIBG

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Receiving a medication which inhibits tumor uptake of iobenguane I 131
• Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject

Contacts and Locations

Locations

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

Molecular Insight Pharmaceuticals, Inc.

More Information

• Responsible Party: Molecular Insight Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT02961491
• Other Study ID Numbers: MIP-IB12B-EAP
• First Posted: November 11, 2016
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:

MIBG; Azedra; Rare neuroendocrine tumors; Iobenguane I 131; Progenics

Additional relevant MeSH terms:

Pheochromocytoma; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; 3-Iodobenzylguanidine; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals