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Status:

TERMINATED

Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases

Lead Sponsor:

Case Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cognitive/Functional Effects

Metastatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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...

Detailed Description

OBJECTIVES: Primary * Determine the CNS progression-free survival rate in patients with 1-3 newly diagnosed brain metastases treated with sunitinib malate after stereotactic radiosurgery (SRS). Sec...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2014

    Estimated Enrollment :

    14 Patients enrolled

    Trial Details

    Trial ID

    NCT00910039

    Start Date

    April 1 2009

    End Date

    April 1 2014

    Last Update

    September 29 2014

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Henry Ford Health System

    Detroit, Michigan, United States, 48202

    2

    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44106

    3

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44195