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Experimental Immune-Boosting drug now available for bone cancer patients

NCT ID NCT04571229

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This expanded access program offers L-MTP-PE, an investigational drug that activates white blood cells to fight cancer, to people with osteosarcoma. Eligible patients include those with newly diagnosed or relapsed osteosarcoma who have had surgery to remove all detectable cancer. The drug is given as an infusion over 36 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
L-MTP-PE (a drug that activates white blood cells to help the immune system kill cancer cells)
What this could lead to
If it works, this could provide a treatment option for people with osteosarcoma, especially those who have not responded to standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so effectiveness is not proven. The drug is still investigational and may not work for everyone. Side effects are possible.

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.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible. * Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma * L-MTP-PE is deemed to be of potential benefit by the treating investigator * Willing and able to understand and sign informed consent and assent as appropriate * Life expectancy \> 6 weeks * Adequate organ function as follows: * Adequate bone marrow function defined as: * absolute neutrophil count (ANC) ≥ 750/mm\^3 * platelet count ≥ 30,000/ mm\^3 * hemoglobin ≥ 8 g/dl * Adequate renal function defined as: * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m\^2 OR * Serum creatinine ≤ 2x the upper limit of normal based on age/gender * Adequate liver function defined as: * Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease * AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases * Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant Exclusion Criteria: * Use of chronic steroids of other immunosuppressive agents * Pregnant or breast feeding

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Conditions

The condition(s) this trial relates to.

osteosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteosarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    AVAILABLE

    New York, New York, 10065, United States

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