This phase I trial studies the side effects and best dose of TPI 287 when given together with fractionated stereotactic radiation therapy in treating patients with breast or non-small cell lung cancer that has spread to the brain. TPI 287 may help fractionated stereotactic radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Stereotactic radiation therapy delivers several small doses of radiation directly to the tumor over several days to kill and shrink tumors. Giving TPI 287 with fractionated stereotactic radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02187822.
PRIMARY OBJECTIVES:
I. To evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) of TPI 287 given concurrently with fractionated stereotactic radiotherapy (FSRT) to treat brain metastases from advanced breast and non-small cell lung (NSCL) cancers.
SECONDARY OBJECTIVES:
I. To characterize the pharmacokinetics and anti-tumor effect of TPI 287 administered concurrently with FSRT in the treatment of patients with breast and NSCL cancers metastatic to the brain; and to evaluate the effect of treatment on measures of quality of life.
OUTLINE: This is a dose-escalation study of TPI 287.
Patients receive TPI 287 intravenously (IV) over 60 minutes on days 1, 8, and 15. Approximately 4 hours after TPI 287 administration, patients undergo fractionated stereotactic radiation therapy once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 18 months.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorSolmaz Sahebjam
