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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Terminated; Phase 2

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

Treatments: Other: cognitive assessment; Drug: sunitinib malate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00910039

CASE1308 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Sunitinib malate

Experimental group

Description:

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.

Treatment:

Drug: sunitinib malate

Other: cognitive assessment