Clinical trial NCT04770831: Patients Who Receive 131 I-MIBG
Official title: An Observational Study of Patients With Recurrent Progressive or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma Who Receive 131 I- MIBG
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain and Nervous System
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life
timeFrame: For up to 2 years after treatment with 131 I-MIBG
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From on study date to date of progression or death, for up to 5 years
measure: Disease Control Rate
timeFrame: From on study date to off study date, for up to 5 years
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Javier Oesterheld, MD
role: PRINCIPAL_INVESTIGATOR
References: