Stereotactic Radiosurgery in Treating Patients with Brain Metastasis

Inclusion Criteria

• Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor
• Radiographic evidence by magnetic resonance imaging (MRI) (or by computed tomography [CT] scan with CT contrast if ineligible or intolerant of MRI) of brain metastasis; (If patient is unable to tolerate MRI contrast, an MRI without contrast is acceptable if lesions are visible)
• All brain metastases must be outside the brain stem (midbrain, pons and medulla)
• Patient must have 10 or less brain metastases
• The maximum diameter of any lesion must be less than or equal to 3.0 cm
• Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that: * Radiation was not to the brain * Surgery to the brain was >= 7 days prior to SRS and there remains at least one additional brain metastasis that can be targeted with SRS
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 2 or better/Karnofsky Performance Status score of 50-60 or better
• All men, as well as women of child-bearing potential 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 participating in this study, she should inform her treating physician immediately * A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy; or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Medically acceptable birth control (contraceptives) includes: ** Approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or ** Barrier methods (such as a condom or diaphragm) used with a spermicide (a substance that kills sperm)
• Ability to understand and the willingness to sign a written informed consent
• A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Medically acceptable birth control (contraceptives) includes: * Approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or * Barrier methods (such as a condom or diaphragm) used with a spermicide (a substance that kills sperm)

Exclusion Criteria

• Patients who have had chemotherapy, immunotherapy or any targeted therapy within 7 days prior to anticipated SRS treatment date or those planning for systemic therapy within 7 days following the protocol treatment
• Patients had craniotomy and surgery to the brain within 7 days from the date of SRS
• Patients with leptomeningeal metastasis * NOTE: For the purposes of exclusion, leptomeningeal disease (LMD) is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement; Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs; In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD; In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator’s discretion based on level of clinical suspicion
• Patients with a contraindication to both MRI (with or without contrast) and CT scan (with contrast)
• Patients with life expectancy < 3 months
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• Psychiatric illness/social situations that would limit compliance with study requirements
• Subjects must not be pregnant or nursing at the time of SRS treatment due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants