Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases
Condition: Cognitive/Functional Effects; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Brain Neoplasms
Intervention: sunitinib malate; cognitive assessment
Intervention description: Treatment will be administered on an outpatient basis. Patients will receive sunitinib 37.5mg once daily in the morning without regard to meals in repeated 6-week cycles comprising daily therapy for 4 weeks followed by a 2-week rest period. Patients who tolerate this dose may increase the dose to 50 mg once daily.; The memory test has six alternate forms. The other tests measure motor and information processing speed and are relatively resistant to the effects of practice. The total time for test administration, including the QOL and symptom measures, is 40 minutes.The difference between the pre-treatment baseline and follow-up assessment scores will be determined by the reliable change (RC) index. This index is derived from the standard error of measurement (SEM) for each test in the battery: 1 (deterioration), 2 (no change), or and 3 (improved).
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cognitive/functional effects; tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib malate works after stereotactic
      radiosurgery in treating patients with newly diagnosed brain metastases.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed carcinoma

          -  Has 1-3 newly diagnosed brain metastases amenable to stereotactic radiosurgery

          -  Patients may enroll up to 1 month after the completion of stereotactic radiosurgery
             provided they can undergo the required neuropsychiatric battery before beginning
             treatment.

          -  Patients must begin treatment within 1 month of stereotactic radiosurgery.

          -  No CNS metastases from lymphoma or small cell lung cancer

          -  No leptomeningeal metastases

          -  No CNS complications requiring urgent neurosurgical intervention (e.g., resection or
             shunt placement)

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100% (RTOG RPA class I or II)

          -  Life expectancy > 6 weeks

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL (transfusion allowed)

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Total serum bilirubin ≤ 1.5 times ULN

          -  Serum calcium ≤ 12.0 mg/dL

          -  Serum creatinine ≤ 2.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing and able to comply with schedule visits, treatment plans, laboratory tests,
             and other study procedures

          -  No medical problem (unrelated to the malignancy) that would pose an undue risk or that
             would limit full compliance with the study

          -  No unresolved bowel obstruction

          -  No uncontrolled infectious process

          -  No evidence of bleeding diathesis or coagulopathy

               -  Hematuria from a primary renal tumor is allowed provided all other eligibility
                  criteria are met

          -  No hypertension that cannot be controlled by medications to a blood pressure of <
             160/90 mm Hg

          -  None of the following within the past 6 months:

               -  Myocardial infarction

               -  Severe/unstable angina

               -  Severe peripheral vascular disease (claudication) or procedure on peripheral
                  vasculature

               -  Coronary/peripheral artery bypass graft

               -  NYHA class II-IV congestive heart failure

               -  Cerebrovascular accident or transient ischemic attack

               -  Clinically significant bleeding

               -  Deep venous thrombosis or pulmonary embolism

          -  No other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or that may interfere with the interpretation of study results
             and, in the judgement of the investigator, would make the patient inappropriate for
             entry into this study

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior sunitinib malate

          -  No prior cranial external beam radiotherapy

          -  No concurrent coumadin or other agents containing warfarin, except for low-dose
             coumadin (≤ 1 mg) administered prophylactically for maintenance of in-dwelling lines
             or ports

          -  No concurrent hepatic enzyme-inducing anticonvulsants

          -  No concurrent participation in another clinical trial

          -  No other concurrent investigational agents

          -  Concurrent steroids allowed provided dose is stable for ≥ 1 week

          -  Concurrent systemic therapy for management of stable systemic disease allowed