Actively Recruiting
A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-17
45
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 at least one extrapulmonary metastasis or unresectable metastases at diagnosis (Cohort 1)
- Radiographically confirmed complete response from initial therapy and relapsed metastatic high-risk osteosarcoma (Cohort 2)
- Newly diagnosed osteosarcoma not eligible for Cohorts 1 or 2 with planned research biopsy (Cohort 3)
- Age between 6 and 49 years at enrollment (Cohorts 1 and 2)
- Karnofsky or Lansky performance score above 50% within 28 days prior to enrollment (Cohorts 1 and 2)
- Ability to swallow oral medication in tablet or capsule form
- Adequate blood counts, kidney, liver, and heart function as defined by specific laboratory and cardiac criteria
- Willingness to assent or consent to research biopsies as applicable
- Adequate biopsy tumor tissue or willingness to undergo pretreatment research biopsy
- Enrollment on MSK IRB 12-245 biospecimen research protocol with planned oncologic surgeries at MSK
- Agreement to use contraception during study therapy and for 12 months after completion
- Willingness and ability to comply with study treatment and scheduled visits
You will not qualify if you...
- Receiving other investigational agents for osteosarcoma therapy (Cohorts 1 and 2)
- Uncontrolled chronic or active infection or condition contraindicating study therapy
- History of significant heart disease including uncontrolled hypertension, serious arrhythmias, unstable angina, heart failure, or prior heart attack
- Receiving additional cancer treatments besides study drugs
- Medical or surgical conditions interfering with oral drug absorption
- Prior cardiac radiation therapy
- Previous enrollment in OstEvo study (Cohort 2 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Asmin Tulpule, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here