What side effects are associated with this type of intervention?

Common treatments for Neuroblastoma, particularly those involving antibody therapies like Hu3F8, often include side effects such as pain at the site of the tumor, fever, allergic reactions, and capillary leak syndrome. Other potential side effects can include low blood pressure, difficulty breathing, and infusion-related reactions. These treatments aim to target tumor antigens but can also affect normal cells, leading to these adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for neuroblastoma, including antibody-based therapies targeting tumor antigens. One notable example is dinutuximab, an anti-GD2 monoclonal antibody, which targets the GD2 antigen expressed on neuroblastoma cells. This treatment has shown efficacy in improving survival rates in high-risk neuroblastoma patients. Other therapies may include combinations with chemotherapy, immunotherapy, and supportive care to enhance treatment outcomes.

What other types of research exist?

Promising novel alternatives to Hu3F8 for Neuroblastoma patients include: 1) GD2-targeting antibodies such as dinutuximab, which has shown efficacy in high-risk neuroblastoma. 2) CAR T-cell therapies targeting GD2, which are in clinical trials and have shown potential in early-phase studies. 3) ALK inhibitors like crizotinib for patients with ALK mutations. 4) Anti-PD1/PDL1 therapies, which are being explored for their potential to enhance immune response against neuroblastoma.

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Hu3F8 PET Imaging for Brain Cancer

N/A

Waitlist Available

Led By Shakeel Modak, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Have refractory or relapsed or metastatic disease

Patients with the diagnosis of neuroblastoma must meet both of the following criteria:

Must not have

Requirement for sedation for PET/CT scans

Acute life threatening infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how a special protein called Hu3F8 moves through the body and targets tumors. Hu3F8 is designed to attach to tumor cells, helping the immune system recognize and destroy them. The study focuses on patients with tumors to see how well this protein works in attacking cancer cells.

Who is the study for?

This trial is for people aged 3-90 with certain types of cancer (like neuroblastoma, melanoma, sarcoma) that have come back or spread and show GD2 on their cells. They must be able to follow the study plan and women who can have babies need to use birth control. People can't join if they're allergic to iodide/Lugols, had bad reactions to similar drugs before, are pregnant/breastfeeding, or too sick in other ways.

What is being tested?

The trial is testing a lab-made antibody called Hu3F8 tagged with radioactive iodine (124I). It's designed to see how this antibody moves in the body and targets tumors that have a specific substance on their surface.

What are the potential side effects?

Possible side effects might include allergic reactions due to sensitivity towards iodine or Lugols products used in the process. There could also be issues related to major organ functions but specifics aren't provided.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned or spread and is not responding to treatment.

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I have been diagnosed with neuroblastoma.

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My cancer has returned or spread and can be measured.

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My cancer is known to have GD2 on its cells.

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I have been diagnosed with osteogenic sarcoma.

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I have been diagnosed with fibrosarcoma.

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I have been diagnosed with spindle cell sarcoma.

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My medulloblastoma has spread outside my brain.

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My diagnosis was confirmed by a pathology department or by bone marrow metastases and high urine catecholamines.

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I have been diagnosed with Leiomyosarcoma.

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I have been diagnosed with Ewing sarcoma.

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I have been diagnosed with malignant fibrous histiocytoma.

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My condition is small cell lung cancer.

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My cancer has returned or didn't respond to treatment and is in an advanced stage.

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I am between 3 and 90 years old.

Exclusion Criteria

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

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I need sedation to undergo PET/CT scans.

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I do not have a severe, life-threatening infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

radioactivity measured to determine pharmacokinetics of 124I-hu3F8

Secondary study objectives

PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8

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: PET Imaging using 124I-Humanized 3F8Experimental Treatment1 Intervention

124I-hu3F8 at a dose of 3mCi/m2 (with a maximum dose of 5mCi) will be injected IV. 124I-hu3F8 PET/CT scans will be performed at approximately 2-4 hours, 18-26hours, 48-72 hours and 96-144 hours after injection of 124I-hu3F8. A low dose CT scan will be obtained with each PET scans. PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8 and to determine dosimetry to organs and sites of disease. Comparison of tumor targeting and tumor dosimetry will be made between the two cohorts of patients: (a) NB and (b) other solid tumors. Blood will be drawn where feasible at multiple time points: approximately 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120h-144h after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.

0 / 17Eligibility 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

Antibody-based therapies, such as those involving Hu3F8, work by targeting specific antigens present on the surface of Neuroblastoma cells. These antibodies bind to the antigens, marking the cancer cells for destruction by the immune system. This targeted approach helps to minimize damage to healthy cells, reducing side effects compared to traditional chemotherapy. For Neuroblastoma patients, this is crucial as it offers a more precise treatment option that can improve outcomes and quality of life by leveraging the body's immune response to fight the cancer.