RecruitingPhase 2NCT07477457

A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma

OstEvo - Osteosarcoma Evolves


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

45 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study to find out whether adding gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy is a more effective treatment approach for people with osteosarcoma than standard chemotherapy on its own. The researchers will also look at the safety of adding these drugs to standard chemotherapy. The researchers will also use the additional research biopsies from Cohort 1 participants to learn more about how osteosarcoma survives during chemotherapy.


Eligibility

Min Age: 6 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of targeted drugs — gefitinib, trametinib, disulfiram, and sunitinib — added to standard chemotherapy for people with osteosarcoma (a type of bone cancer). There are two groups: newly diagnosed patients with cancer that has spread, and patients whose cancer has returned after going into remission. **You may be eligible if...** - You have been newly diagnosed with metastatic (spread) osteosarcoma, especially with spread outside the lungs or with tumors that cannot be surgically removed, OR - Your osteosarcoma went into complete remission after treatment but has now come back within 24 months of starting first chemotherapy - You may have started standard chemotherapy but must join the study within 29 days of starting it - You are in good enough health to participate **You may NOT be eligible if...** - Your bone cancer has never spread or returned - You have already received too many cycles of prior chemotherapy - You have significant organ problems, active infections, or other serious health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethotrexate

Methotrexate 12 g/m\^2 (max dose 20 grams) intravenously over 4 hours or as per institutional standard.

DRUGDoxorubicin

Doxorubicin 37.5 mg/m\^2 intravenously over 15 to 30 minutes or as per institutional standard.

DRUGCisplatin

Cisplatin 60 mg/m\^2 intravenously over 4 hours or as per institutional standard.

DRUGGefitinib

Gefitinib 400 mg/m\^2/dose (maximum dose 250 mg) orally daily for 14 days (14 doses)

DRUGTrametinib

Trametinib will be dispensed as per institutional standard.

DRUGDisulfiram

Disulfiram 250 to 500 mg orally once daily for 14 days

DRUGSunitinib

Sunitinib capsules for under 18 years of age: 15 mg/m\^2/dose (maximum 50 mg) orally once daily x 14 days

DRUGIfosfamide

Ifosfamide 2,800 mg/m\^2 intravenously as per institutional standard.

PROCEDUREBiopsy

Research biopsy prior to therapy


Locations(7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07477457


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