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Cytokine

Hu3F8 + GM-CSF for Osteosarcoma

Phase 2

Waitlist Available

Led By Filemon Dela Cruz, 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

Adequate cardiac function: shortening fraction of ≥ 28% or ejection fraction ≥ 50%

Prior treatment with other anti-GD2 antibodies allowed (prior treatment with Hu3F8 not allowed), HAHA antibody titer must be negative

Must not have

Presence of overt metastatic disease at any site

Patients with OS in first complete remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an antibody and drug combo to see if it can keep cancer in remission or prevent it from coming back.

Who is the study for?

This trial is for people aged 1-40 who have recurrent osteosarcoma and are in at least their second complete remission. They must have normal organ function, no overt metastases, not be pregnant or breastfeeding, and can't have had the study drug before. Participants need to agree to use birth control and should not have a life-threatening infection.

What is being tested?

The trial tests Humanized Monoclonal Antibody 3F8 (Hu3F8) combined with GM-CSF on patients with recurrent osteosarcoma. It aims to see if this combination helps keep patients in remission longer without the cancer coming back.

What are the potential side effects?

Possible side effects of Hu3F8 with GM-CSF may include allergic reactions, pain or swelling at injection sites, fever, chills, fatigue, nausea or vomiting. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My heart is strong enough, with good pumping ability.

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I've had treatments with anti-GD2 antibodies but not Hu3F8, and I don't have HAHA antibodies.

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I don't have trouble breathing at rest and can exercise without issues.

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My cancer is in its second or later complete remission.

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My kidney function is within the normal range.

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I can take care of myself but might not be able to do heavy physical work.

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I am between 1 and 40 years old.

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My liver tests are within the required range.

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My osteosarcoma has come back, confirmed by tissue analysis.

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My blood cell counts are within the required range and I don't need transfusions.

Exclusion Criteria

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

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My cancer has spread to other parts of my body.

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My cancer is in its first complete remission.

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I do not have a severe infection that is putting my life at risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

event free survival (EFS)

Secondary study objectives

time to recurrence

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: humanized anti-GD2 antibody, hu3F8, when combined with GM-CSFExperimental Treatment2 Interventions

One cycle consists of treatment with hu3F8 at a dose of 2.4mg/kg/dose for 3 days (day 1, 3, and 5) in the presence of subcutaneous (sc) GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. Cycles are repeated at \~2-4 week intervals between first days of hu3F8, through 5 cycles. A maximum of 5 cycles will be administered on protocol. If elevations of amylase and/or lipase (\>Grade 1) or clinical signs suggestive of pancreatitis (e.g. upper abdominal pain) occurs, naxitamab and GM-CSF doses should be held until improvement of toxicity to ≤Grade 1 if laboratory elevations and/or pancreatitis is possibly related to either naxitamab or GM-CSF.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GM-CSF

2014

Completed Phase 4

~1350

0 / 13Eligibility criteria met