Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain
• * Extracranial metastases allowed
• Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following:
• * External beam radiotherapy
• * Brachytherapy
• * Stereotactic radiosurgery
• * Surgery
• * Chemotherapy
• * Treatments with investigational drugs, biologics, or devices
• Disease progression in the CNS must meet ≥ 1 of the following criteria:
• * New lesions in the CNS on an imaging study (contrast-enhanced CT scan or MRI)
• * Progressive lesions on an imaging study (contrast-enhanced CT scan or MRI)
• New or progressive lesions that do not meet measurable disease definition allowed
• Leptomeningeal disease allowed if concurrent progression or parenchymal brain metastases
• Not a candidate for surgical resection and/or further stereotactic radiosurgery
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 1 month
• Hemoglobin ≥ 10 g/dL (transfusion allowed)
• ANC ≥ 1,500/mm³
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 mg/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• Must be able to swallow and retain oral medications
• No other active malignancy except for any of the following:
• * Curatively treated basal or squamous cell carcinoma of the skin
• * Carcinoma in situ of the cervix
• * Other malignancies considered disease-free
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast
• No other known contraindication to MRI including, but not limited to, any of the following:
• * Cardiac pacemaker
• * Implanted cardiac defibrillator
• * Brain aneurysm clips
• * Cochlear implant
• * Ocular foreign body
• * Shrapnel
• No active or uncontrolled infection
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Recovered from the side effects of prior chemotherapy, surgery, or radiotherapy for extracranial disease or brain metastases
• Concurrent trastuzumab, bisphosphonate, and/or corticosteroid therapy allowed
• At least 1 week since prior or on current stable dose of corticosteroid therapy
• Concurrent coumadin allowed
• No prophylactic use of filgrastim (G-CSF) during first course of treatment