Compassionate Use of 131I-MIBG for Patients with Malignant Pheochromocytoma

Sponsor: University of California, San Francisco

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Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01377532

Provider View

This study offers a treatment option for patients with malignant pheochromocytoma and paragangliomas, focusing on providing relief from symptoms.

Patient Parameters

Program Overview

This study is designed to provide a treatment option for patients with malignant pheochromocytoma and paragangliomas, which are rare tumors that can occur in both children and adults. These tumors sometimes spread to other parts of the body, making them difficult to treat. Traditional chemotherapy often doesn't work well for these patients and can cause severe side effects. This study uses a treatment called 131I-MIBG, which aims to help manage symptoms and improve quality of life for patients who have not responded to other treatments.

Description

Pheochromocytomas and paragangliomas are rare types of tumors that can develop in both children and adults. They occur in about 2-8 people per million each year. These tumors can sometimes spread to other parts of the body, which is known as metastasis. Traditional chemotherapy treatments for these tumors often involve a combination of drugs like cyclophosphamide, vincristine, and dacarbazine. However, these treatments are not effective for most patients with metastatic pheochromocytoma or paraganglioma, and they can cause severe side effects such as bone marrow suppression and nerve damage. Some patients have seen improvements with a drug called sunitinib, but it can also cause serious side effects, and experience with this drug is limited. Patients who do respond to chemotherapy often have to continue treatment indefinitely to maintain remission, but the side effects can be so severe that they have to stop treatment. This study offers an alternative treatment option using 131I-MIBG, which aims to provide symptom relief for patients who have not responded to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pheochromocytoma or paraganglioma that has returned or is not responding to treatment.
  • Age over 2 years and able to follow safety guidelines during treatment.
  • Tumors cannot be safely removed by surgery or have spread to other areas.
  • Life expectancy of more than 3 months.
  • Performance status of 70% or higher, meaning able to carry out normal activities with some effort.
  • May have had previous treatments, but must have recovered from any side effects.
  • Must meet specific blood and organ function criteria.
  • Must not have had certain types of radiation therapy recently.
  • Must not have received certain medications recently.
  • Must have normal lung and heart function.

Exclusion Criteria

  • Have a serious disease affecting major organs that would make treatment unsafe.
  • Have protein in the urine without infection four weeks before treatment.
  • Cannot be pregnant or breastfeeding due to potential risks to the baby.
  • Must use effective birth control to prevent pregnancy during the study.
  • Cannot be on hemodialysis.
  • Cannot have active infections that are severe.

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