Patients Who Receive 131 I-MIBG

Brain and Nervous System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04770831
• Other study ID #: IRB00081388
• Secondary ID: 00047671LCI-PED-
• Status: Withdrawn
• Start date: March 10, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain and Nervous System

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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