Expanded Access Program for Ultratrace Iobenguane I131 in Treating Difficult Pheochromocytoma/Paraganglioma

Sponsor: Molecular Insight Pharmaceuticals, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02961491

Provider View

This program offers access to the treatment AZEDRA for patients with pheochromocytoma or paraganglioma that has returned or is difficult to treat. It aims to assess the safety of AZEDRA in these patients.

Patient Parameters

Program Overview

This study provides access to AZEDRA, a treatment for patients with pheochromocytoma or paraganglioma that has come back or is hard to treat. The goal is to evaluate how safe and tolerable AZEDRA is for these patients, who have tumors that absorb iobenguane.

Description

The main study on AZEDRA, which looked at how well it works and its safety in treating pheochromocytoma and paraganglioma, has finished enrolling patients. This expanded access program allows new patients with these conditions, whose tumors absorb iobenguane, to receive AZEDRA. The study will also gather more information on the safety of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Willing to give consent and follow study requirements.
  • Diagnosed with pheochromocytoma or paraganglioma, confirmed by tests or tumor markers.
  • Cannot have surgery to cure the condition.
  • Tried other treatments without success or have no other treatment options.
  • Tumors must absorb iobenguane, confirmed by a test dose.
  • Expected to live at least 6 months according to a doctor.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Men or women who can have children and are not using birth control during and for 6 months after treatment.
  • Active brain lesions found in scans within 3 months.
  • Severe heart problems or unstable heart conditions.
  • Recent bone marrow damage from radiation therapy.
  • Previous treatment with iobenguane I 131 or whole-body radiation within 12 weeks.
  • Previous radiation to more than 25% of bone marrow.
  • Recent chemotherapy or experimental treatments within 30 days.
  • Other active cancers needing treatment, except minor skin cancers.
  • Poor overall health status.
  • Significant lab test abnormalities before treatment.
  • History of AIDS/HIV.
  • Ongoing alcohol abuse or liver disease, including hepatitis.
  • Allergy to iobenguane needing medical treatment.
  • Taking medications that affect iobenguane absorption.
  • Any other condition that may affect safety or study participation.

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