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| ID | Type | Description | Link |
|---|---|---|---|
| 00047671 | Other Identifier | Advarra IRB | |
| LCI-PED-NEU-MIBG-001 | Other Identifier | Atrium Health |
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difficult enrollment, no subjects consented or enrolled
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This study is for patients who have have neuroblastoma, pheochromocytoma, or paraganglioma that has come back (relapsed) after treatment or has not gotten better (refractory) with standard treatment. The purpose of this study is to evaluate quality of life and response rate to 131 I-MIBG treatment.
This is an observational, single institution study designed to determine the benefit of 131I-MIBG therapy in subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors. Response rate, time to progression, and quality of life changes will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | QOL following MIBG |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | To assess health related quality of life prior to, during and after therapy with 131 I-MIBG. For subject's ≥8 years of age, their patient reported Peds QL will be compared to their caregiver's perspective. | For up to 2 years after treatment with 131 I-MIBG |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | To assess progression free survival (PFS) to 131I-MIBG therapy for subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors. | From on study date to date of progression or death, for up to 5 years |
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Inclusion Criteria
Subject must meet all of the following applicable inclusion criteria to participate in this study:
Exclusion Criteria
Subjects meeting the criteria below may not participate in the study:
1. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.
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Subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors will be recruited at Levine Cancer Institute (LCI), Torrence E. Hemby Jr. Pediatric Hematology & Oncology Center, or Atrium Health Levine Children's Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Javier Oesterheld, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Disease Control Rate |
To evaluate disease control rate to 131I-MIBG treatment in subjects with refractory, relapsed or progressive neuroblastoma or other neuroendocrine tumors (not limited to but including malignant pheochromocytoma or paraganglioma). |
| From on study date to off study date, for up to 5 years |