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Cytokine

Hu3F8 + GM-CSF for Osteosarcoma

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

event free survival (EFS)

Secondary outcome measures

time to recurrence

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

~1340

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesOTHER

231 Previous Clinical Trials

5,076,582 Total Patients Enrolled

2 Trials studying Osteosarcoma

102 Patients Enrolled for Osteosarcoma

M.D. Anderson Cancer CenterOTHER

2,965 Previous Clinical Trials

1,804,760 Total Patients Enrolled

14 Trials studying Osteosarcoma

461 Patients Enrolled for Osteosarcoma

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,511 Total Patients Enrolled

1 Trials studying Osteosarcoma

12 Patients Enrolled for Osteosarcoma

Media Library

GM-CSF (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT02502786 — Phase 2

Osteosarcoma Research Study Groups: humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF

Osteosarcoma Clinical Trial 2023: GM-CSF Highlights & Side Effects. Trial Name: NCT02502786 — Phase 2

GM-CSF (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02502786 — Phase 2

Frequently Asked Questions

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

Is this investigation a groundbreaking case of its kind?

"GM-CSF has been extensively researched, with the first trials sponsored by Y-mAbs Therapeutics in 2011. Following successful Phase 1 clinical testing involving 68 patients, several live studies have since followed across 8 cities and 9 countries."

Answered by AI

Does this experiment admit geriatric individuals?

"According to the enrollment requirements, patients must be between 13 months and 40 years old. Meanwhile, there are 233 studies available for minors while 958 clinical trials pertain to seniors 65 or older."

Answered by AI

How many subjects have been enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov documents show that this medical study, initially posted on the 1st of July 2015, is recruiting patients currently. This clinical trial aims to enlist 46 individuals from 3 different sites."

Answered by AI

Is there still an opportunity to join this experiment?

"Based on the data available from clinicaltrials.gov, this medical study is presently enrolling patients. The trial was made public on July 1st 2015, and its details were last updated in November 17th 2022."

Answered by AI

What research has been conducted in relation to the use of GM-CSF?

"The initial investigation of GM-CSF took place in 2011 at Memorial Sloan Kettering Cancer Center. Thus far, 41 studies have been concluded with 7 trials ongoing as of now; many of these are hosted by medical centres situated in Houston, Texas."

Answered by AI

What potential risks does GM-CSF pose to those who utilize it?

"This Phase 2 trial has evidence to suggest that GM-CSF is safe, resulting in an estimated score of 2 on our Power scale. Unfortunately, there is not yet any data supporting its efficacy."

Answered by AI

Recent research and studies

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

clinicaltrials.govStudy

Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

2015. "Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02502786.

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