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67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023331
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Clarity Pharmaceuticals Ltd

Brief Summary:
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: 67Cu-SARTATE Drug: 64Cu-SARTATE Phase 1 Phase 2

Detailed Description:
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 67Cu-SARTATE. Once either the 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 up to 2 therapy cycles of 67Cu-SARTATE at the MTD dose level.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arm Intervention/treatment
Experimental: 67Cu-SARTATE

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 a slow IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive up to 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion.

Drug: 67Cu-SARTATE
67Cu-labelled MeCOSar-Tyr3-octreotate
Other Name: Cu-67 SARTATE, copper 67 SARTATE

Drug: 64Cu-SARTATE
64Cu-labelled MeCOSar-Tyr3-octreotate
Other Name: Cu-64 SARTATE, copper 64 SARTATE




Primary Outcome Measures :
  1. Maximum Tolerated Dose of 67Cu-SARTATE [ Time Frame: 6 weeks ]
    MDT as determined by cohort observations of DLTs

  2. Safety and tolerability of Cu-67 SARTATE using CTCAE version 4.03 [ Time Frame: Up to 12 months ]
    Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.

  3. Safety and tolerability of Cu-64 SARTATE using CTCAE version 4.03 [ Time Frame: Up to 12 months ]
    Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.

  4. Objective response and best response [ Time Frame: 6 to 8 weeks post final therapy ]
    For patients receiving at least 1 administration of 67Cu-SARTATE, as assessed by INRC.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor participants, with the minor providing age appropriate assent, according to local law and regulations;
  2. Life expectancy ≥ 12 weeks;
  3. Known high-risk neuroblastoma with failure to respond to standard therapy (combination chemotherapy with or without radiation and surgery), or development of PD at any time;
  4. Adequate recovery from acute toxic effects of any prior therapy, as deemed by the Investigator or treating Sub-Investigator;
  5. Adequate liver function as defined by the following laboratory values obtained within 28 days prior to administration of 64Cu-SARTATE: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN);
  6. Adequate renal function;
  7. Adequate laboratory parameters: Absolute neutrophil count > 1.0 x 109/L; Platelet count > 50 x 109/L; Serum bilirubin <1.5 x ULN;
  8. Karnofsky or Lansky performance status ≥50;
  9. All participants must have a hematopoietic stem cell product available (minimum CD34+ cell dose is ≥2 x 106 cells/kg);
  10. Sexually active participants of reproductive potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus. Abstinence is considered acceptable;
  11. 64Cu-SARTATE uptake on the 4 hour scan (SUVmax) of any lesion equal to or higher than that of the liver in order to move on to the therapy phase of the study.

Exclusion Criteria:

  1. Participants with disease of any major organ system that would compromise their ability to tolerate therapy, as deemed by the Investigator or treating Sub-Investigator;
  2. Any other active malignancy, or a history of prior malignancy within the past 3 years;
  3. History of cardiac failure as evidenced by: dyspnea at rest, exercise intolerance, oxygen requirement, clinically significant cardiac dysfunction;
  4. Planned administration of chemotherapy, anti-cancer cytokine therapy, immunotherapy, radiotherapy including radiopharmaceuticals or other investigational agents within 2 weeks prior to the administration of 64Cu-SARTATE and 4 weeks prior to the administration of 67Cu-SARTATE;
  5. Administration of therapeutic dose of 131I-MIBG within 8 weeks prior to the administration of 64Cu-SARTATE;
  6. Administration of any investigational agents within 28 days prior to administration of 64Cu-SARTATE;
  7. Treatment with long acting somatostatin analogues (administered within 28 days prior to the administration of 64Cu-SARTATE), or short acting somatostatin analogues (administered within 24 hours prior to the administration of 64Cu-SARTATE);
  8. Known sensitivity or allergy to somatostatin analogues;
  9. Previous PRRT;
  10. Female participants who are pregnant or lactating;
  11. Participants who are on hemodialysis;
  12. QTc interval ≥ 0.45 seconds as measured by Screening ECG;
  13. Participants with uncontrolled infection(s);
  14. Any medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
  15. Participants 12 month and younger will be excluded from cohorts where the planned single or cumulative administered activity is modelled to deliver a radiation dose to the marrow that exceeds 2 Gy.

Information from the National Library of Medicine

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


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neeta Pandit-Taskar, MD    212-639-3046      
Contact: Ellen Basu, MD    212-639-5204      
Principal Investigator: Neeta Pandit-Taskar, MD         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Clarity Pharmaceuticals Ltd
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Responsible Party: Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT04023331    
Other Study ID Numbers: CL04
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs