67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT04023331|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Relapsed Neuroblastoma Refractory Neuroblastoma||Drug: 67Cu-SARTATE Drug: 64Cu-SARTATE||Phase 1 Phase 2|
This is an 'adaptive trial'. The trial design uses the accumulating data from the ongoing trial to modify aspects of the trial (e.g. dose, number of treatments). The trial is also a 'personalised trial' as the interval between treatments and number of treatments is determined for each patient individually.
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase.
Dose escalation will be completed using a modified 3+3 study design with up to 4 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 1 therapy cycle of 67Cu-SARTATE.
Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the International Neuroblastoma Response Criteria (INRC) guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Cohort expansion will commence once either the Maximum Tolerated Dose (MTD) for a single administration of 67Cu-SARTATE is established, or Cohort 4 has been completed. The study will be expanded to enroll an additional 10 subjects who will receive at least 2 therapy cycles of 67Cu-SARTATE at the MTD dose level. Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the INRC guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
The study also includes a long-term follow-up period to 36 months following the first dose of 67Cu-SARTATE, although in person study visits are not required.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial|
|Actual Study Start Date :||August 18, 2020|
|Estimated Primary Completion Date :||December 2028|
|Estimated Study Completion Date :||December 2028|
64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle at a rate of 2.0 MBq/kg.
67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as an IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive at least 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion.
Participants in either phase of the study that demonstrate therapeutic benefit following treatment with 67Cu-SARTATE at any dose may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Other Name: Cu-67 SARTATE, copper 67 SARTATE
Other Name: Cu-64 SARTATE, copper 64 SARTATE
- Maximum Tolerated Dose (MTD) of 67Cu-SARTATE [ Time Frame: 6 weeks ]MDT as determined by cohort observations of Dose Limiting Toxicities
- Safety and tolerability of Cu-67 SARTATE using Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 36 months ]Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, electrocardiograms (ECGs) and spontaneous adverse event (AE) reporting.
- Safety and tolerability of Cu-64 SARTATE using CTCAE [ Time Frame: Up to 36 months ]Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
- Overall response rate [ Time Frame: Up to 12 months ]As assessed by international neuroblastoma response criteria (INRC).
- Best response [ Time Frame: 6 to 8 weeks post final therapy ]As assessed by international neuroblastoma response criteria (INRC).
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): NCT04023331
|Contact: Clarity Pharmaceuticals||+61 (0) 2 9209 firstname.lastname@example.org|
|United States, Arizona|
|Phoenix Children's Hospital||Not yet recruiting|
|Phoenix, Arizona, United States, 85016|
|Principal Investigator: Francis Eshun, MD|
|United States, Missouri|
|Washington University School of Medicine||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator: Frederick Huang, MD|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Principal Investigator: Neeta Pandit-Taskar, MD|
|United States, North Carolina|
|Atrium Health/ Levine Children's Hospital||Not yet recruiting|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator: Giselle Sholler, MD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Centre||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator: Brian Weiss, MD|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator: Jacquline Kraveka, MD|
|United States, Texas|
|University of Texas Southwestern Medical Centre||Recruiting|
|Dallas, Texas, United States, 75390|
|Principal Investigator: Tanya Watt, MD|
|MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Douglas Harrison, MD|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator: Kenneth DeSantes, MD|