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

Phase 2

Terminated

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

Interventions: Drug: sunitinib malate
Other: cognitive assessment

Registration Number: NCT00910039

Lead Sponsor: Case Comprehensive Cancer Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib malate	cognitive assessment	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.
Sunitinib malate	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.

Primary Outcome Measures

Name	Time	Method
Central Nervous System (CNS) Progression-free Survival Rate	6 months after stereotactic radiosurgery (SRS)	The number of subjects surviving at least six months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald's standard criteria.Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months from SRS	The number of subjects surviving at least 12 months from stereotactic radiosurgery.
Central Nervous System (CNS) Progression-free Survival Rate	12 months after stereotactic radiosurgery (SRS)	The number of subjects surviving at least 12 months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald's standard criteria. Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.
Rate of Local Failure at 12 Months	12 months	Rate of local vs regional failure -rates of progression at site of stereotactic radiosurgery (local failure)vs progression anywhere else in CNS (regional failure).
Median Time to CNS Disease Progression	up to12 months from SRS	Time to disease progression will be recorded from the first day of protocol therapy until the criteria for disease progression are met, patient death from any cause or removal of the patient from study for any reason, whichever comes first.
Neurocognitive Effects	at 2 months after treatment	The number of patients that had statistically significant change (p's \> 0.05) in their neurocognitive assessment (improvement or decline) from baseline. Neurocognitive function was assessed in several domains, including memory, verbal fluency, visual-motor speed, executive function and motor dexterity.The difference between the pre-treatment baseline and follow-up assessment scores were determined by the reliable change (RC) index. RC Index: 1=deterioration, 2=no change, 3=improved
Safety and Tolerability	3 years from study start	Number of patients that experienced treatment-related G 3-4 adverse events.
Time to Progression	at 3 yrs from SRS	Time to progression (all sites of disease) - interval between stereotactic radiosurgery and the earliest date of progression (systemic or CNS) or death due to any cause.

Trial Locations

Locations (3): 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