What side effects are associated with this type of intervention?

Common treatments for neuroblastoma, including targeted radiotherapy like 67Cu-SARTATE, often involve side effects such as nausea, vomiting, and fatigue. Hematologic toxicities are also prevalent, including thrombocytopenia, lymphopenia, anemia, and leukopenia, which can lead to increased risk of infections and bleeding. Nephrotoxicity and hepatotoxicity are potential risks due to the radiopharmaceuticals used. Additionally, long-term risks may include myelodysplastic syndrome and acute myeloid leukemia, particularly in patients heavily pretreated with alkylating agents.

What prior FDA approvals exist?

The FDA has approved several treatments for neuroblastoma, though specific approvals for therapies similar to 67Cu-SARTATE, which uses a somatostatin analog linked to copper-67, are not explicitly mentioned. However, the concept of peptide receptor radionuclide therapy (PRRT) using radiolabeled somatostatin analogs has been explored in other cancers, such as gastroenteropancreatic neuroendocrine tumors, with agents like 177Lu-DOTATATE. These therapies target somatostatin receptors on tumor cells, delivering targeted radiation to destroy cancer cells while sparing surrounding healthy tissue. For neuroblastoma, traditional treatments have included chemotherapy, radiation therapy, and more recently, immunotherapy and targeted therapies, but specific PRRT approvals for neuroblastoma are not detailed in the provided context.

What other types of research exist?

Promising alternatives to 67Cu-SARTATE for neuroblastoma patients include 177Lu-DOTATATE, which has shown efficacy in treating somatostatin-receptor-positive tumors. Additionally, high-dose chemotherapy with autologous peripheral blood stem cell transplantation and novel immunotherapies, such as anti-GD2 monoclonal antibodies, are also being explored as effective treatments for high-risk neuroblastoma.

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Peptide Receptor Radionuclide Therapy

Peptide Receptor Radionuclide Therapy for Neuroblastoma

Phase 1 & 2

Recruiting

Research Sponsored by Clarity Pharmaceuticals Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky or Lansky performance status ≥50

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

Must not have

Administration of therapeutic dose of 131I-MIBG within 8 weeks prior to the administration of 64Cu-SARTATE

Previous peptide receptor radionuclide therapy (PRRT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called 67Cu-SARTATE for children with high-risk neuroblastoma. The treatment uses radiation to target and kill cancer cells. The goal is to see if this approach is safe and effective for these patients.

Who is the study for?

This trial is for pediatric patients with high-risk neuroblastoma that's relapsed or not responding to standard treatments. They must have a life expectancy of at least 12 weeks, adequate organ function, and a minimum performance status of 50. Participants need available stem cells for transplant and must use effective birth control if applicable.

What is being tested?

The study tests the safety and effectiveness of a therapy called 67Cu-SARTATE in children with aggressive neuroblastoma. Patients first undergo a scan using 64Cu-SARTATE to ensure their tumors absorb the drug well enough before receiving the actual treatment.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to radiation exposure from the radionuclide therapy such as nausea, fatigue, kidney damage, blood cell count changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities but may need help.

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My scan shows a lesion as active as or more than my liver.

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I have a stem cell product ready for use with enough cells.

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My liver tests, AST and ALT, are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I received a specific radioactive treatment within the last 8 weeks.

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I have undergone peptide receptor radionuclide therapy.

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I am older than 12 months and eligible for treatments with higher radiation doses.

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I have a history of heart failure with symptoms like shortness of breath or needing oxygen.

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I am not pregnant or breastfeeding.

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I am currently receiving hemodialysis.

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I have not had any other cancer in the last 3 years.

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I do not have any infections that are currently uncontrolled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best response

Maximum Tolerated Dose (MTD) of 67Cu-SARTATE

Overall response rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 67Cu-SARTATEExperimental Treatment2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

64Cu-SARTATE

2015

Completed Early Phase 1

~10

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuroblastoma treatments often include chemotherapy, surgery, and targeted radiotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while surgery aims to remove the tumor physically. Targeted radiotherapy, such as 67Cu-SARTATE, involves using a somatostatin analog linked to a radioactive isotope like copper-67. This compound binds to somatostatin receptors, which are often overexpressed on neuroblastoma cells, delivering targeted radiation that kills the cancer cells while sparing surrounding healthy tissue. This targeted approach is crucial for Neuroblastoma patients as it potentially reduces side effects and improves treatment efficacy.