Clinical Trials / Research Studies

Clinical Trials / Research Studies

CL04: 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma

Why are we doing this research?

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 2 therapy cycles of 67Cu-SARTATE at the MTD dose level.

CL04: 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.

Who can participate?

Inclusion Criteria:

  • 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;
  • Life expectancy ≥ 12 weeks;
  • 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;
  • Adequate recovery from acute toxic effects of any prior therapy, as deemed by the Investigator or treating Sub-Investigator;
  • 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);
  • Adequate renal function;
  • Adequate laboratory parameters: Absolute neutrophil count > 1.0 x 109/L; Platelet count > 50 x 109/L; Serum bilirubin <1.5 x ULN;
  • Karnofsky or Lansky performance status ≥50;
  • All participants must have a hematopoietic stem cell product available (minimum CD34+ cell dose is ≥2 x 106 cells/kg);
  • 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;
  • 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:

  • 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;
  • Any other active malignancy, or a history of prior malignancy within the past 3 years;
  • History of cardiac failure as evidenced by: dyspnea at rest, exercise intolerance, oxygen requirement, clinically significant cardiac dysfunction;
  • Planned administration of chemotherapy, anti-cancer cytokine therapy, immunotherapy, radiotherapy or other investigational agents within 2 weeks prior to the administration of 64Cu-SARTATE and 4 weeks prior to the administration of 67Cu-SARTATE;
  • Administration of therapeutic dose of 131I-MIBG within 8 weeks prior to the administration of 64Cu-SARTATE;
  • EBRT to both kidneys or a single functioning kidney within 12 months prior to the administration of 64Cu-SARTATE;
  • Administration of any investigational agents within 28 days prior to administration of 64Cu-SARTATE;
  • 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);
  • Known sensitivity or allergy to somatostatin analogues;
  • Previous PRRT;
  • Female participants who are pregnant or lactating;
  • Participants who are on hemodialysis;
  • QTc interval ≥ 0.45 seconds as measured by Screening ECG;
  • Participants with uncontrolled infection(s);
  • Any medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
  • 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.

Ages

  • No lower or upper limits  

Conditions

  • Neuroblastoma Relapse - Refractory
  • Adult - Neuroblastoma Relapse - Refractory

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org