Trial Summary
What is the purpose of this trial?The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene involved in cellular growth of chordoma cells. During this research study, subjects will also receive radiation therapy which is considered a standard treatment for advanced chordomas. It is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without adding significant toxicities.
The purpose of this research study is to determine the safety of nilotinib when used in combination with radiation therapy, and the highest dose of nilotinib that can be given safely with radiation therapy.
Eligibility Criteria
This trial is for individuals with high-risk chordoma, a type of bone cancer. Participants must have a life expectancy over 3 months, be able to swallow capsules, and have measurable disease with proper organ function. It's not open to those who've had certain heart issues, are on strong CYP3A4 inhibitors or anticoagulants like coumadin, have gastrointestinal problems affecting drug absorption, acute pancreatitis, CNS infiltration by cancer cells, another primary cancer needing treatment, recent major surgery without recovery or investigational agent use within the last month.Inclusion Criteria
My cancer is confirmed to be chordoma through tissue examination.
Measurable disease
My condition is considered high risk.
+3 more
Exclusion Criteria
I haven't had major surgery in the last 4 weeks or I've recovered from it.
Treatment with other investigational agents within 30 days of Day 1
I have another cancer that needs treatment through the bloodstream.
+12 more
Participant Groups
The study tests Nilotinib combined with radiation therapy in treating advanced chordomas. Nilotinib is believed to slow tumor growth by targeting specific genes in the tumor cells. The goal is to find out how safe this combination is and the highest dose of Nilotinib that can be given safely alongside standard radiation treatments.
1Treatment groups
Experimental Treatment
Group I: Nilotinib/XRTExperimental Treatment2 Interventions
Nilotinib is administered 400mg PO BID for 2 weeks and then administered concurrently with daily radiation therapy until completion of radiation therapy. Participants can then undergo surgery if clinically possible. After either surgery or definitive radiation, participants have the option to continue on nilotinib therapy.
Nilotinib is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
🇪🇺 Approved in European Union as Tasigna for:
- Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib
🇺🇸 Approved in United States as Tasigna for:
- Chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adult patients resistant to or intolerant to prior therapy that included imatinib
🇨🇦 Approved in Canada as Tasigna for:
- Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib
🇯🇵 Approved in Japan as Tasigna for:
- Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib
🇨🇭 Approved in Switzerland as Tasigna for:
- Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor