Dosimetry Guided PRRT With 177Lu-DOTATATE in Children
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|ClinicalTrials.gov Identifier: NCT03923257|
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Neuroblastoma Pheochromocytoma Paraganglioma||Drug: 177Lu-DOTA-tyr3-OCTREOTATE Procedure: Peptide Receptor Radiotherapy (PRRT)||Phase 1 Phase 2|
The purpose of this clinical trial is to determine if peptide receptor radiotherapy (PRRT) using 177Lu-DOTA-OCTREOTATE given intravenously in children is an effective treatment and to describe its toxicities.
This study will consists of two groups:
Group A - children age 18 months to 18 years with relapsed or refractory neuroendocrine tumors and pheochromocytoma or paraganglioma.
Group B - children age 6 months to 18 years with relapsed or refractory neuroblastoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3 OCTREOTATE (177Lu-DOTATATE) in Children With Neuroendocrine Tumor, Neuroblastoma, or Pheochromocytoma/Paraganglioma|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: PRRT with 177Lu-DOTA-tyr3-OCTREOTATE
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 consists of two groups:
Group A - Children age 18 months to 18 years with relapsed or refractory neuroendocrine tumors and pheochromocytoma or paraganglioma. Children with neuroendocrine tumor, pheochromocytoma or paraganglioma will not have had any previous endoradiotherapy with 90Y-DOTATOC, 131I-MIBG, or 177Lu-DOTATATE.
Group B - Children age 6 months to 18 years with relapsed or refractory neuroblastoma. Children with neuroblastoma may have received previous 131I-MIBG treatment and must have dosimetry estimates of that radiation dose before receiving 177Lu-DOTATATE therapy in this study.
This is a peptide receptor radiotherapy that targets somatostatin receptors on tumor cells.
Other Name: Lutathera
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.
- Toxicities [ Time Frame: Initiation of treatment through 5 years ]
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.
- Objective Response Rate (ORR) according to RECIST criteria in children [ Time Frame: Initiation of treatment through 5 years ]To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) + stable disease [SD] per RECIST v1.1)
- Measure and demonstrate accuracy of radiation dose to kidneys in children based on a single SPECT/CT image of the kidneys plus a single whole body scan [ Time Frame: Initiation of treatment through treatment #4 (approximately 26 weeks) ]
Six subjects in each group 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 .
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.
- Measure and demonstrate accuracy of radiation dose to bone marrow in children based on radioactivity in a single blood sample [ Time Frame: Initiation of treatment through treatment #4 (approximately 26 weeks) ]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 Free Survival (PFS) according to RECIST criteria in children [ Time Frame: Initiation of treatment through 5 years ]Progression will be defined using the RECIST 1.1 guidelines. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
- Measure effect of PRRT in quality of life with the PROMIS Pediatric Profile v2.0 - Profile-37 [ Time Frame: Initiation of treatment through treatment #4 (approximately 26 weeks) ]Parents of participants will be asked to complete the PROMIS Pediatric Profile v2.0 - Profile-37
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923257
|Contact: M. Sue O'Dorisio, MD, PhDfirstname.lastname@example.org|
|Contact: Silvia Ghobrial, MDemail@example.com|
|Principal Investigator:||M. Sue O'Dorisio, MD, PhD||University of Iowa|