A Phase I/IIA Study of 64Cu-SARTATE and 67Cu-SARTATE for Imaging and Treating Children and Young Adults with High-Risk Neuroblastoma

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Full 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

Purpose

Researchers doing this study to find out whether it is safe to give 64Cu-SARTATE (an imaging agent) and 67Cu-SARTATE (an investigational treatment) to children and young adults with neuroblastoma that either cannot be treated, did not improve with treatment, or came back after treatment. They will be assessing different doses of 67Cu-SARTATE to find the highest safe dose. Both drugs are given intravenously (by vein).

64Cu-SARTATE and 67Cu-SARTATE contain a form of copper that gives off a dose of radiation. They target a protein called SSTR2, which is sometimes found on the surface of cancer cells. Researchers are using the imaging agent to find out whether this receptor is present on patients’ neuroblastoma cells. If a patient’s first PET/CT scan shows that the imaging agent has attached to this protein, then 67Cu-SARTATE will also attach to it and potentially be useful for treating neuroblastoma.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have neuroblastoma that either cannot be treated, did not improve with treatment, or came back after treatment.
  • Patients may not receive anticancer treatment within 2 weeks of 64Cu-SARTATE or 4 weeks of 67Cu-SARTATE.
  • This study is for patients age 1 year and older.

For more information about this study and to inquire about eligibility, please contact Dr. Neeta Pandit-Taskar at 212-639-3046.

Protocol

20-218

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators