Clinical trial NCT00910039
Conditions: Cognitive/Functional Effects Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific
Keywords: cognitive/functional effects tumors metastatic to brain unspecified adult solid tumor, protocol specific
Sponsor: Case Comprehensive Cancer Center
Start date: 2009-04-01; Completion date: 2014-04-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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.
Interventions: intervention 1: sunitinib malate intervention 2: cognitive assessment
Intervention descriptions: intervention 1: 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 2: 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).

Protocol documents: