Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases
Condition: Breast Cancer; Metastatic Cancer
MeSH terms: Breast Neoplasms
Intervention: irinotecan hydrochloride; temozolomide
Intervention MeSH terms: Irinotecan; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer; male breast cancer; tumors metastatic to brain

Summary:

      RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with
      temozolomide and to see how well it works in treating patients with breast cancer who have
      received previous treatment for brain metastases.
    

Eligibility criteria:

        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

          -  Patients on an enzyme-inducing anti-epileptic agent (EIAE) or valproic acid are
             eligible if they are switched to an alternate non-EIAE medication

          -  Concurrent coumadin allowed

          -  No prophylactic use of filgrastim (G-CSF) during first course of treatment