NCT03273712

Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

Phase II, Dosimetry Guided, Peptide Receptor Radiotherapy (PRRT) Using 90Y-DOTA tyr3-Octreotide (90Y-DOTATOC) in Children and Adults With Neuroendocrine and Other Somatostatin Receptor Positive Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 6 Months – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.

Detailed description

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors. The somatostatin receptor targeting of the therapeutic will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy. Treatment consists of 3 cycles, 6-8 weeks apart. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the total renal dose. The goals of this project are to 1. Demonstrate the safety and efficacy of dosimetry-guided peptide receptor radiotherapy using 90Y-DOTA-tyr3-Octreotide in patients with neuroendocrine and other somatostatin receptor expressing tumors. 2. Monitor all adverse events associated with peptide receptor radiotherapy using 90Y-DOTATOC. 3. Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an accurate technique for diagnosis, staging, treatment targeting, and monitoring response to 90Y-DOTATOC therapy.

Conditions

• Neuroendocrine Tumors
• Meningioma
• Neuroblastoma
• Medulloblastoma

Interventions

Type	Name	Description
RADIATION	90Y-DOTA tyr3-Octreotide	90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
DIAGNOSTIC_TEST	68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan	68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
DRUG	Amino Acids	This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.

Timeline

• Start date: 2017-09-29
• Primary completion: 2020-05-27
• Completion: 2020-05-27
• First posted: 2017-09-06
• Last updated: 2023-02-09
• Results posted: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study