Patients Who Receive 131 I-MIBG

An Observational Study of Patients With Recurrent Progressive or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma Who Receive 131 I- MIBG

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04770831

Enrollment

Registered

2021-02-25

Start date

2021-03-10

Completion date

2024-12-01

Last updated

2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Nervous System

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 30 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Quality of Life	For up to 2 years after treatment with 131 I-MIBG	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.

Secondary

Measure	Time frame	Description
Progression Free Survival (PFS)	From on study date to date of progression or death, for up to 5 years	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.
Disease Control Rate	From on study date to off study date, for up to 5 years	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).

Countries

United States

Outcome results