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

NCT ID: NCT00910039

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-04-30

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 how well sunitinib malate works after stereotactic radiosurgery in treating patients with newly diagnosed brain metastases.

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).

Secondary

• Determine the rate of local (site of SRS treatment) failure at 12 months in these patients.
• Determine the median time to CNS disease progression in these patients.
• Determine the overall survival of these patients.
• Determine the time to progression of systemic disease in these patients.
• Evaluate the safety of sunitinib malate when administered after SRS in these patients.
• Assess the neurocognitive effects of SRS followed by sunitinib malate in these patients.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life.

Conditions

Cognitive/Functional Effects; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib malate

Oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life.

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

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.

cognitive assessment

Intervention Type: OTHER

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).

Interventions

sunitinib malate

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.

Intervention Type: DRUG

cognitive assessment

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 Type: OTHER

Other Intervention Names

SUNITINIB L-Malate salt; SU010398; PHA-290940AD; Sutent; SUNITINIB; Cognitive Function Tests: Memory Hopkins Verbal Learning Test; Verbal fluency Controlled Oral Word Association; Visual-motor speed Trail Making Test Part A; Executive Function Trail Making Test Part B; Motor dexterity Grooved Pegboard 3; Function Test: Quality of life (QOL) was evaluated with a self-report measure (FACT-BRREF).

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M. Peereboom, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Henry Ford Health System

Detroit, Michigan, United States

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

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE1308

Identifier Type: OTHER

Identifier Source: secondary_id

CASE1308

Identifier Type: -

Identifier Source: org_study_id