Nilotinib With Radiation for High Risk Chordoma

Status: Recruiting
Phase: Phase 1
Diagnosis: Sarcoma
NCT ID: NCT01407198 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-072

 

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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Edwin Choy, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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
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