TPI 287 and Fractionated Stereotactic Radiation Therapy in Treating Patients with Brain Metastases from Breast or Non-small Cell Lung Cancer

Inclusion Criteria

• Patients must have histologically or cytologically confirmed non-central nervous system primary breast or non-small cell lung cancer
• Patients must have pathologically or radiologically confirmed metastatic disease in the brain
• Patients with up to 3 brain metastases (symptomatic and non-symptomatic) can be treated on this study; maximum diameter of each brain lesion should be =< 5 cm; maximum tumor volume =< 120 cc
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy of greater than 12 weeks
• Patients requiring treatment with corticosteroids are eligible
• Treatment with non-enzyme inducing anti-seizure medications is allowed
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR calculated creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Systemic chemotherapy washout period >= 7 days; for investigational dugs and monoclonal antibodies washout period >= 5 x drug half-life; there are no limitations on number of prior treatment regimens
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of TPI 287 administration
• Prior brain surgery or radiation is allowed as long as the metastatic lesion(s) to be targeted in this study has not previously been treated with radiation
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who have had chemotherapy within 1 week (6 weeks for nitrosoureas or mitomycin C) or investigational therapies/monoclonal antibodies within 5 half-life of investigational compound or those who have adverse events which are greater than grade 1 and are due to agents administered more than 1 week earlier; bisphosphonates, endocrine therapy, and trastuzumab are permitted without restriction
• Patients who are receiving any other investigational agents
• Previous treatment of the target lesions with radiation therapy
• Patients who have previously been treated with whole brain radiation
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to TPI 287
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with TPI 287
• Known contraindication to enhanced magnetic resonance imaging (MRI) and computed tomography (CT) scan
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled seizure activity or psychiatric illness/social situations that would limit compliance with study requirements