Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma (NCT01377532) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma
United States
Plain-language summary
This is a compassionate use protocol to allow palliative therapy for patients with malignant pheochromocytoma and paragangliomas.
Who can participate
Age range2 Years
SexALL
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Inclusion Criteria:
* Diagnosis: Refractory or relapsed PHEO/PGL with original diagnosis based on tumor histopathology or the finding of PHEO/PGL tumor cells in the bone marrow. The diagnosis may also be based upon the presence of high plasma fractionated metanephrines or high urine catecholamines/metanephrines with diagnostic MIBG uptake.
* Age: \> 2 years and able to cooperate with radiation safety restrictions during therapy period.
* Disease status: It must be determined that either the PHEO/PGL tumors are not amenable to safe surgical resection or are metastatic. Disease evaluable by MIBG scan must be present within 6 weeks of study entry and subsequent to any intervening therapy.
* Life Expectancy: greater than 3 months.
* Lanksy and Karnofsky Performance Status: 70% or higher.
* Prior Therapy: Patients may enter this study with or without having had other therapy for recurrent tumor. Patients may be treated who have not had chemotherapy or radiation therapy. Patients may also be treated who have failed to respond to standard chemotherapy or radiation therapy. Patients must have fully recovered from the toxic effects of any prior therapy. At least 2 weeks should have elapsed since any anti-tumor therapy and the patient must meet hematologic criteria below. Three months should have elapsed in the case of completing radiation to any of the following fields: total craniospinal, total abdominal, whole lung, total body irradiation). Cytokine therapy (eg G-CSF, GM-CSF, IL-6,…