Study on Adding Gefitinib, Trametinib, Disulfiram, and Sunitinib to Standard Chemotherapy for Osteosarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07477457
This clinical trial is exploring whether adding four additional drugs—gefitinib, trametinib, disulfiram, and sunitinib—to standard chemotherapy can improve treatment outcomes for people with osteosarcoma. The study will also assess the safety of this combination and use biopsy samples to understand how osteosarcoma responds to treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if adding the drugs gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy is more effective for treating osteosarcoma than using standard chemotherapy alone. Researchers will also evaluate the safety of this drug combination and use biopsy samples to learn more about how osteosarcoma survives during chemotherapy.
Eligibility Criteria
Inclusion Criteria
Cohort 1: Newly Diagnosed, Metastatic Osteosarcoma
- Must have a new diagnosis of high-risk metastatic osteosarcoma, confirmed by biopsy.
- Must have at least one metastasis outside the lungs or metastases that cannot be surgically removed.
- Can have started standard chemotherapy but must join the study before day 29 of starting chemotherapy.
Cohort 2: Relapsed, Metastatic Osteosarcoma
- Must have had a complete response to initial therapy and then relapsed with high-risk metastatic osteosarcoma.
- Relapse must meet specific criteria, such as occurring within 24 months of starting first chemotherapy or involving multiple lung nodules.
- Must join the study before day 22 of the first cycle post-relapse.
Cohort 3: Other Osteosarcoma Cases
- Newly diagnosed osteosarcoma not eligible for Cohorts 1 or 2.
- Must be enrolled in a specific research protocol and have planned surgeries at MSK.
- Must consent to a research biopsy before starting chemotherapy.
Cohorts 1 and 2:
- Age between 6 and 50 years.
- Must have metastatic high-risk osteosarcoma.
- Must be able to swallow oral medications.
- Must have adequate organ function, including blood, kidney, liver, and heart function.
- Must consent to research biopsies and provide tumor tissue samples.
- Must agree to use contraception during and after the study if of childbearing potential.
- Must be willing to comply with study procedures and visits.
Exclusion Criteria
Cohorts 1 and 2:
- Cannot be receiving other investigational drugs for osteosarcoma.
- Cannot have uncontrolled infections or conditions that make the study drugs unsafe.
- Cannot have a history of certain heart diseases or uncontrolled high blood pressure.
- Cannot be taking other cancer-specific medications.
- Cannot have conditions that affect the absorption of oral medications.
- Cannot have had prior radiation to the heart.
Cohort 2:
- Cannot have been previously enrolled in the OstEvo study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering at Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering at Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | 10065 | New York | New York |
| Memorial Sloan Kettering at Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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