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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:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing how well the study drug, Hu3F8, works in people with certain types of brain tumors.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

radioactivity measured to determine pharmacokinetics of 124I-hu3F8

Secondary outcome measures

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

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 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,613 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,784 Patients Enrolled for Neuroblastoma

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,550 Total Patients Enrolled

12 Trials studying Neuroblastoma

1,185 Patients Enrolled for Neuroblastoma

Shakeel Modak, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

9 Previous Clinical Trials

377 Total Patients Enrolled

7 Trials studying Neuroblastoma

320 Patients Enrolled for Neuroblastoma

Media Library

124I-Humanized 3F8 Clinical Trial Eligibility Overview. Trial Name: NCT02307630 — N/A

Neuroblastoma Clinical Trial 2023: 124I-Humanized 3F8 Highlights & Side Effects. Trial Name: NCT02307630 — N/A

124I-Humanized 3F8 2023 Treatment Timeline for Medical Study. Trial Name: NCT02307630 — N/A

Neuroblastoma Research Study Groups: PET Imaging using 124I-Humanized 3F8

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors aged 75 and up included in this medical trial's participant pool?

"Participants of this trial must be 3 years old or older, yet younger than 90 years."

Answered by AI

Are there still opportunities for participants to join this research endeavor?

"This clinical trial is no longer searching for new participants, having been originally posted on November 1st 2014 with its last update occurring December 1st 2022. Should you seek alternative studies, there are currently 1289 trials recruiting patients with sarcoma and 8 research projects open to those afflicted by 124I-Humanized 3F8."

Answered by AI

How many individuals have enrolled in this clinical trial thus far?

"At this point, recruitment for the trial has concluded. It first appeared on November 1st 2014 and was last updated on December 1st 2022. If you are looking to join a clinical study related to sarcoma or 124I-Humanized 3F8 specifically, there are currently 1289 and 8 trials respectively that may be of interest."

Answered by AI

Could you elucidate on the research surrounding 124I-Humanized 3F8?

"Presently, there are 8 trials that investigate the effectiveness of 124I-Humanized 3F8. All of them are in preclinical stages and none have progressed to Phase 3 yet. These investigations primarily occur within New york City but they span 33 total medical sites throughout America."

Answered by AI

Is this trial a pioneering endeavor?

"Y-mAbs Therapeutics first began researching 124I-Humanized 3F8 in 2011, conducting a clinical trial with 68 patients. After this initial study was completed successfully, Phase 1 approval for the drug was granted and now there are 8 separate trials occurring simultaneously over 9 different countries' cities."

Answered by AI

Are there any criteria for eligibility in this clinical trial?

"This trial is searching for 7 participants with sarcoma, aged between 3 and 90. To qualify, these individuals must have either relapsed or refractory stage 4 disease or MYCN-amplified 2B/3D melanoma, Ewing sarcoma, Spindle cell sarcoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study

2014. "PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02307630.

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