Nilotinib With Radiation for High Risk Chordoma

NCT ID: NCT01407198

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

Nilotinib will be taken orally daily in two cycles of 28 days each. Two weeks after taking nilotinib, subjects will begin radiation therapy. Radiation therapy will continue every weekday until Day 56 of the study. If it is determined that the subject's tumor cannot be removed by surgery, an additional 3 weeks of radiation therapy will be applied after Day 56 of the study.

During study visits subjects will have physical exams, routine blood tests, urine and blood clotting tests, and EKGs. Subjects will also have tumor assessment by chest CT and MRI or CT of the tumor at screening, on approximately Day 56 of the study, then every 6 months for one year and then annually thereafter if ther is no disease progression.

Conditions

Chordoma

Keywords

High Risk Chordoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nilotinib/XRT

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.

Group Type: EXPERIMENTAL

Nilotinib

Intervention Type: DRUG

Orally, daily 200 - 400 mg BID

Radiation therapy

Intervention Type: RADIATION

External beam radiation will be delivered at 1.8 Gy per day, 5 days per week (excluding holidays)for a total of 28 fractions over a 6 weeks period.

Interventions

Nilotinib

Orally, daily 200 - 400 mg BID

Intervention Type: DRUG

Radiation therapy

External beam radiation will be delivered at 1.8 Gy per day, 5 days per week (excluding holidays)for a total of 28 fractions over a 6 weeks period.

Intervention Type: RADIATION

Other Intervention Names

AMN 107; Tasigna; External beam radiation

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed chordoma
• Considered to have high risk disease
• Measurable disease
• Life expectancy > 3 months
• Adequate organ function
• Able to swallow oral capsules

Exclusion Criteria

• Previous treatment with any other tyrosine kinase inhibitor
• Previous treatment with radiotherapy to the primary or recurrent chordomas
• Impaired cardiac function
• Currently receiving treatment with strong CYP3A4 inhibitors
• Requires anticoagulation with coumadin
• Impaired GI function or GI disease that may significantly alter the absorption of study drug
• Acute or chronic pancreatic disease
• Known cytopathologically confirmed CNS infiltration
• Another primary malignant disease which requires systemic treatment
• Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
• History of significant congenital or acquired bleeding disorder unrelated to cancer
• Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery
• Treatment with other investigational agents within 30 days of Day 1
• History of non-compliance to medical regimens
• Pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Edwin Choy, MD

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edwin Choy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-072

Identifier Type: -

Identifier Source: org_study_id