NCT03923257

Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents

Phase I Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3-Octreotate (177Lu-DOTATATE) in Children and Adolescents With Neuroendocrine Tumor or Pheochromocytoma/Paraganglioma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sue O'Dorisio · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II peptide receptor radiotherapy (PRRT) trial of 177Lu-DOTA-OCTREOTATE in children and adolescents with neuroendocrine tumors and pheochromocytoma or paraganglioma.

Detailed description

The purpose of this clinical trial is to determine if peptide receptor radiotherapy (PRRT) using 177Lu-DOTA-OCTREOTATE given intravenously in children and adolescents is an effective treatment and to describe its toxicities. This study will consists of children and adolescents ages 1-20 years with relapsed or refractory neuroendocrine tumors and pheochromocytoma or paraganglioma.

Conditions

• Neuroendocrine Tumors
• Pheochromocytoma
• Paraganglioma

Interventions

Type	Name	Description
DRUG	177Lu-DOTA-tyr3-OCTREOTATE	This is a peptide receptor radiotherapy that targets somatostatin receptors on tumor cells.
PROCEDURE	Peptide Receptor Radiotherapy (PRRT)	PRRT is internal radiation that is individually dosed according to patient body surface area, kidney function and bone marrow status.

Timeline

• Start date: 2020-08-04
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2019-04-22
• Last updated: 2021-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study