Neoplasms

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Rare Diseases

Neuroendocrine Tumors

Pheochromocytoma

Paraganglioma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Paragangliomas 1

Neuroepithelioma

All Drugs and Chemicals

Somatostatin

Lutetium Lu 177 dotatate

Edotreotide

Radiopharmaceuticals

177Lu-DOTA-tyr3-OCTREOTATE (177Lu-DOTATATE) and amino acid will be administered intravenously (IV) on Day 1 of each of four treatment cycles, 8 weeks apart.

This study will consist of children and adolescents ages 1-20 years with relapsed or refractory neuroendocrine tumors and pheochromocytoma or paraganglioma. Children and adolescents with neuroendocrine tumor, pheochromocytoma or paraganglioma will not have had any previous endoradiotherapy with 90Y-DOTATOC, 131I-MIBG, or 177Lu-DOTATATE.

This is a peptide receptor radiotherapy that targets somatostatin receptors on tumor cells.

177Lu-DOTA-tyr3-OCTREOTATE

PRRT is internal radiation that is individually dosed according to patient body surface area, kidney function and bone marrow status.

Peptide Receptor Radiotherapy (PRRT)

M. Sue O'Dorisio, MD, PhD

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.

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.

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

To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients

Adverse events will be reported in tabular form by type and grade. Adverse events will be graded according to the most recent CTE guidelines.

To determine overall response rate (ORR) (complete response \[CR\] + partial response \[PR\]) + stable disease \[SD\] per RECIST v1.1)

Six subjects will have whole body imaging and SPECT/CT of kidneys performed at 3-8 hours plus whole body and SPECT at 20-28 hours, 44-52 hours, 92-100 hours and 116-124 hours after the administration of the radiopharmaceutical. Data will be analyzed using method of Madsen\[1,2\]. Single point dosimetry will be utilized with subsequent cohorts if data demonstrates agreement with adult dosimetry. Biological effective dose (BED) to kidneys will be calculated according to Bodei et al \[3\].

The information on renal uptake, renal mass and residence time will be entered into OLINDA software to calculate the radiation dose. If single point dosimetry proves to be accurate, any remaining Phase I subjects and all Phase II subjects will receive single point dosimetry for both renal and bone marrow radiation dose estimation.

Blood dosimetry will be performed as a surrogate of bone marrow dosimetry. Blood samples (1 mL) will be obtained prior to start of amino acid infusion and subsequently in the same time frame with the imaging sessions.

Progression will be defined using the RECIST 1.1 guidelines. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.

Parents of participants will be asked to complete the PROMIS Pediatric Profile v2.0 - Profile-37

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents	NCT03923257	Neuroendocrine ... Pheochromocytom... Paraganglioma	177Lu-DOTA-tyr3... Peptide Recepto...	1 Year - 20 Years	University of Iowa
Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents	NCT03923257	Neuroendocrine ... Pheochromocytom... Paraganglioma	177Lu-DOTA-tyr3... Peptide Recepto...	1 Year - 20 Years	University of Iowa

Spots Global Cancer Trial Database for peptide receptor radiotherapy (prrt)