Hu3F8 PET Imaging for Brain Cancer

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Major organ dysfunction, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a lab-made antibody called Hu3F8 (also known as 124I-Humanized 3F8) moves through the body and targets brain tumors. Researchers use a special marker on the antibody to see how well it reaches and affects tumors through PET scans. This trial is designed for individuals with neuroblastoma or other specific solid tumors, such as melanoma or sarcoma, that have recurred or spread. Participants should have measurable tumors and may have previously tried other treatments without success. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this PET imaging method is safe for brain cancer patients?

Research has shown that treatments similar to 124I-Humanized 3F8 are likely safe. In one study with 12 patients using a similar treatment called Iodine-131 3F8, researchers reported no side effects. This suggests the treatment might be safe for people. Another study with 57 patients who had high-risk neuroblastoma found that high doses of humanized 3F8 were well tolerated. Patients did not need to stay in the hospital for monitoring, which indicates a positive safety profile. These findings provide some reassurance about the safety of 124I-Humanized 3F8 in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hu3F8 PET Imaging approach for brain cancer because it uses a novel radiolabeled antibody, 124I-Humanized 3F8, to visualize tumors with high precision. Unlike traditional imaging techniques, this method allows for detailed tracking of how the body absorbs and processes the compound, giving insights into tumor behavior and treatment effectiveness. This unique targeting ability could lead to more personalized and effective treatment plans, potentially improving outcomes for patients with brain cancer by enabling better assessment and monitoring of the disease.

What evidence suggests that this PET imaging method is effective for brain cancer?

Studies have shown that 124I-Humanized 3F8 effectively targets tumors by attaching to specific markers on cancer cells. In this trial, participants will receive 124I-Humanized 3F8, which, when combined with a radioactive marker like 124I, allows doctors to track its movement in the body, particularly its tumor-targeting during PET scans. Previous patients with conditions such as neuroblastoma and melanoma have tolerated the treatment well, indicating its safety and effectiveness. The trial aims to assess how well 124I-Humanized 3F8 can locate and attach to tumors, providing doctors with a clearer view for diagnosis and treatment planning. Early research shows that it accurately highlights cancerous areas, aiding doctors in making better treatment decisions. ^{1 2 3 6 7}

Who Is on the Research Team?

Shakeel Modak, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am willing to use effective birth control during the study.

Signed informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria

Positive human anti-hu3F8 antibody titer.

I need sedation to undergo PET/CT scans.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 124I-hu3F8 and undergo PET/CT scans to analyze biodistribution and dosimetry

1 week

Multiple visits for PET/CT scans and blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 124I-Humanized 3F8

Trial Overview 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.

How Is the Trial Designed?

Group I: PET Imaging using 124I-Humanized 3F8 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Y-mAbs Therapeutics

Industry Sponsor

Trials

26

Recruited

1,600+

Published Research Related to This Trial

Iodine-131 3F8, a monoclonal antibody targeting GD2-bearing tumors, was safely administered to 12 patients with brain tumors, showing effective localization in 9 out of 11 malignant gliomas and one metastatic melanoma without any side effects.

The best tumor delineation was observed with a 10 mCi dose, and the pharmacokinetics were consistent across different doses, indicating that this antibody can effectively target brain tumors with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. Arbit, E., Cheung, NK., Yeh, SD., et al.[2019]

The study of 124I-labeled toripalimab (124I-JS001) in 11 patients with melanoma and urologic cancer showed it to be a safe PET imaging tracer with no adverse events and acceptable dosimetry of 0.236 mSv/MBq.

124I-JS001 demonstrated favorable biodistribution, with high uptake in the spleen and liver, and significantly improved tumor detection when combined with unlabeled JS001, indicating its potential as a tool for identifying patients who may benefit from PD-1 therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron Emission Tomography Imaging of Programmed Death 1 Expression in Cancer Patients Using 124I-Labeled Toripalimab: A Pilot Clinical Translation Study. Wang, S., Zhu, H., Ding, J., et al.[2023]

Citations

1. trials.braintumor.org trials.braintumor.org/trials/NCT02307630

PET Imaging of Solid Tumors Using 124I-Humanized 3F8 Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety ...

2. withpower.com withpower.com/trial/hu3f8-pet-imaging-for-brain-cancer-43804

Hu3F8 PET Imaging for Brain Cancer · Info for Participants ... 124I-Humanized 3F8 will have tolerable side effects & efficacy for patients with Neuroblastoma, Melanoma, Soft Tissue Sarcoma, Neuroblastoma, Melanoma and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02307630

PET Imaging of Solid Tumors Using 124I-Humanized 3F8: ... The purpose of this study is to find out how an antibody called Hu3F8 travels through the body and to tumors.

4. clin.larvol.com clin.larvol.com/trial-detail/NCT02307630

PET Imaging of Solid Tumors Using 124I-Humanized 3F8 Outcome Measure, Measure Description, Time Frame ; PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8, 124I-hu3F8 will be injected ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3397469/

Radioimmunoimaging with longer-lived positron-emitting ... Use of 124I in PET radioimmunoimaging was further demonstrated by c-erb B2 quantification and visualization in tumor xenografts for up to 160 hours using 124I ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6440722/

Humanized 3F8 Anti-GD2 Monoclonal Antibody Dosing ... In this phase 1 clinical trial of 57 patients with high-risk neuroblastoma, high doses of hu3F8 were well tolerated, without a need for inpatient monitoring.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01662804

Humanized 3F8 Monoclonal Antibody (Hu3F8) When ... The purpose of this study is to find out if "humanized 3F8" (Hu3F8) when combined with interleukin-2 (rIL2) is safe for treating neuroblastoma and other ...