Hu3F8 PET Imaging for Brain Cancer

Recruiting in Palo Alto (17 mi)

Overseen byShakeel Modak, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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 have been treated with anti-GD2 antibody, and my antibody levels are low.

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

+22 more

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.

+5 more

Participant Groups

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.

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.