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New antibody combo aims to keep bone cancer at bay
NCT ID NCT02502786
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This phase II trial tests a humanized antibody called Hu3F8 combined with GM-CSF (a drug that boosts the immune system) in children and young adults with recurrent osteosarcoma, a type of bone cancer. The goal is to see if this treatment can extend the time before the cancer returns or prevent relapse altogether. The study enrolls 46 participants who are already in remission after a recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- humanized antibody 3F8 (Hu3F8) and GM-CSF
- What this could lead to
- If it works, this could help keep recurrent osteosarcoma in remission longer and delay or prevent the cancer from coming back.
- What could go wrong
- This is a small, early-phase trial (46 participants) with no control group, so results may not be conclusive. The treatment may cause side effects and might not prevent relapse.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
46 people
The number who actually took part.
- Start date
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Jul 2015
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 months to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.) * Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry. * Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment. * Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery. NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment) * Adequate hematopoietic function defined as: * Absolute neutrophil count ≥ 500/ul * Absolute lymphocyte count ≥ 500/ul * Platelet count ≥ 50,000/ul (transfusion independent) * Adequate hepatic function as defined by: * Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal). * AST (SGOT) of ≤ 3 times upper limit of normal * ALT (SGPT) of ≤ 3 times upper limit of normal * Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal * Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50% * Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance * Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score ≥ 50% * Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative * Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment * Signed informed consent indicating awareness of the investigational nature of this program Exclusion Criteria: * Patients with OS in first complete remission. * Presence of overt metastatic disease at any site. * Active life-threatening infection. * Pregnant women or women who are breast-feeding. * Inability to comply with protocol requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Los Angeles (Data Collection Only)
Los Angeles, California, 90027, United States
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MD ANDERSON CANCER CENTER (Data Collection Only)
Houston, Texas, 77030, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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