Actively Recruiting
A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib Combined with Standard Chemotherapy for Osteosarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-17
45
Participants Needed
7
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the drugs gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy improves treatment outcomes for people with osteosarcoma, a type of bone cancer. This Phase 2 study also aims to assess the safety of combining these drugs with chemotherapy and to better understand how osteosarcoma resists treatment by analyzing additional tumor biopsies from participants in one group. The study focuses on patients with high-risk metastatic osteosarcoma, including newly diagnosed and relapsed cases. Participants will receive standard chemotherapy, either MAP chemotherapy or ifosfamide chemotherapy, alongside one or a combination of the study drugs: gefitinib, trametinib, disulfiram, or sunitinib. Treatment is given in 6 cycles, each lasting 21 or 28 days depending on the chemotherapy type. A separate group will undergo research biopsies without receiving study drugs. The study includes three cohorts based on diagnosis and disease status, with specific criteria for enrollment. During the study, participants will be monitored for progression-free survival over 12 months or overall survival over 24 months, depending on their cohort. They will undergo research biopsies before and during treatment to study tumor response and resistance. Researchers will assess organ function, performance status, and ability to take oral medications. Participants will be followed closely throughout the treatment cycles with scheduled visits and evaluations, and their safety will be monitored carefully throughout the study period.
CONDITIONS
Brief Title
A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed metastatic high-risk osteosarcoma with biopsy confirmation or clinical judgment
- Relapsed metastatic high-risk osteosarcoma meeting specific relapse criteria
- Age over 6 and under 50 years at enrollment
- Karnofsky performance status ≥ 50% for those over 16 years; Lansky score > 50 for under 16 years
- Ability to swallow oral medications as whole tablets or capsules
- Adequate organ function including blood counts, kidney, liver, and heart function
- Willingness to provide informed consent and assent when applicable
- Availability of adequate tumor tissue or willingness to undergo research biopsies
- Enrollment in biospecimen research protocol if having oncologic surgeries at MSK
- Use of effective contraception during and for 12 months after study therapy
- Willingness and ability to comply with study protocol and visits
You will not qualify if you...
- Receiving any other investigational agents for osteosarcoma
- Uncontrolled chronic or active infections or conditions contraindicating study therapy
- History of heart disease including uncontrolled hypertension, significant arrhythmias, unstable angina, heart failure, or prior heart attack
- Use of additional cancer treatments other than study therapy (excluding alternative medications like cannabis)
- Medical or surgical conditions impairing gastrointestinal absorption of oral drugs
- Prior cardiac radiation therapy
- Previous enrollment in this study for relapsed osteosarcoma cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short procedure before treatment begins
Participants undergo a research biopsy prior to starting therapy to collect tumor tissue.
1 visit (in-person)
Duration - Up to 6 treatment cycles of 21 to 28 days each depending on cohort
Participants receive study treatment with chemotherapy and one or more study drugs during multiple cycles.
Visits for each treatment cycle over approximately 18 to 24 weeks
Duration - Up to 24 months
Participants are monitored after treatment to assess progression-free and overall survival.
Periodic visits as scheduled
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
D
Damon Reed, MD
A
Asmin Tulpule, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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