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Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

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

NCT03923257•Sue O'Dorisio

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 20 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Disease not amenable to standard treatment (nonresectable or disease present after one or more surgeries and/or Sandostatin treatment) or subject has failed existing first line chemotherapy, biologic therapy, targeted agent therapy or radiation therapy.
•Participation in Iowa Neuroendocrine Tumor Registry and recommendation by University of Iowa PRRT tumor board.
•A pathologically confirmed (histology or cytology) Neuroendocrine Tumor (NET), Pheochromocytoma (PCC), or Paraganglioma (PGL).
•For patients with measurable or evaluable disease: \>50% of lesions must demonstrate 68Ga-DOTATATE /DOTATOC uptake greater than physiologic liver uptake by visual assessment. At least one lesion must be confirmed by conventional imaging (CT or MRI).
•For patients with measurable disease, the target lesion is one that either has never received external beam radiation or has been previously irradiated and has since demonstrated progression.
•For patients with no measurable disease (no meaurable target lesions), who have evaluable disease (bone disease, MIBG positive disease, liver metastases not detectable on MRI or CT), the disease must be seen on 68Ga-DOTATATE/DOTATOC PET/CT.
•No previous endogenous radiation with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC or 131I-MIBG within 12 months of most recent treatment.
•Age ≥ 18 months \< 20 years at the time of first study drug administration.
•Performance status as determined by Karnofsky ≥ 60 or Lansky Play Scale ≥ 60 at the time of study drug administration.
•NOTE: Neurologic deficits in patients with brain metastases must have been stable for at least 7 days prior to study enrollment.
+15 more criteria

Exclusion Criteria

•Pregnant women are excluded from this study because 177Lu-DOTATATE is a Class C agent with potential teratogenic or abortifacient effects.
•Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 177Lu-DOTATATE, breastfeeding should be discontinued until 3 months after the last administration of study drug.
•Major surgery within 8 weeks of study drug administration.
•External beam radiation to both kidneys (scatter doses of \<500 cGy to a single kidney or radiation to \< 50% of a single kidney is acceptable).
•Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG for this malignancy within 12 months of first study dose.
•Another investigational drug within 8 weeks of study drug administration.
•Concurrent, malignant disease for which patient is on active therapy.
•Another significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocol.
•Subjects who have received Sandostatin LAR or long-acting lanreotide in the past 28 days must be appropriately delayed. Subjects may be maintained on short acting octreotide during the time from last injection of long-acting somatostatin analogue until 8-24 hrs prior to injection of study drug.
•Known antibodies to Octreotide, Lanreotide, or DOTATATE or history of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTATATE.
+11 more criteria

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Key Dates

Start Date

August 4, 2020

Primary Completion Date

June 3, 2021

Completion Date

June 3, 2021

Last Updated

June 8, 2021

Conditions

Neuroendocrine TumorsPheochromocytomaParaganglioma

Interventions

177Lu-DOTA-tyr3-OCTREOTATE

DRUG

Peptide Receptor Radiotherapy (PRRT)

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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