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New antibody combo aims to keep bone cancer at bay

NCT ID NCT02502786

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Jul 2015

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

13 months to 40 years

Sex

Anyone

Healthy volunteers

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

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

  • Children's Hospital of Los Angeles (Data Collection Only)

    Los Angeles, California, 90027, United States

  • MD ANDERSON CANCER CENTER (Data Collection Only)

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

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