Patients Who Receive 131 I-MIBG

Wake Forest University Health Sciences

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Brain and Nervous System

Eligibility

Sex: ALLMin age: 1 YearMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria Subject must meet all of the following applicable inclusion criteria to participate in this study: 1. Written informed consent, and assent where applicable, and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age greater than or equal to 1 years and less than or equal to 30 years at the time of therapy. 3. Subject is scheduled to receive 131 I-MIBG therapy. 4. Diagnosis of refractory, progressive or relapsed Neuroblastoma, Malignant Paraganglioma, Malignant Pheochromocytoma or other Neuroendocrine Tumors. 5. As determined by the enrolling physician, ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study. Exclusion Criteria Subjects meeting the criteria below may not participate in the study: 1\. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: For up to 2 years after treatment with 131 I-MIBG

Secondary Outcomes

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.

Time frame: From on study date to date of progression or death, for up to 5 years

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).

Time frame: From on study date to off study date, for up to 5 years

Data from ClinicalTrials.gov

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