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
Sponsor study identifier
Secondary identifiers
NIH
OTHER · University of Iowa
interventional
39
1 country
1
Study Start
September 29, 2017
Actual (reported)Primary Completion
May 27, 2020
Actual (reported)Study Completion
May 27, 2020
Actual (reported)This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 27, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2017
Actual (reported)September 6, 2017
Actual (reported)September 29, 2017
Actual (reported)May 27, 2020
Actual (reported)May 27, 2020
Actual (reported)February 9, 2023
Actual (reported)Frequency of Tumor Response at 9 Months After Last Treatment
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.
Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
Percentage of Patients With Grade 4 or Higher Renal Adverse Event.
The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.
Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events
The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.
Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
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.
68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
M. Sue O'Dorisio, MD, PhD
University of Iowa
39 participants (actual enrollment reported by the registry).
First Submitted
September 1, 2017
First Posted
September 6, 2017
Study Start
September 29, 2017
Actual (reported)Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 27, 2020
Actual (reported)Study Completion
May 27, 2020
Actual (reported)Last Updated
February 9, 2023
Results First Posted
February 9, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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