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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sunitinib

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