Clinical trial NCT00910039: Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases
Official title: SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Central Nervous System (CNS) Progression-free Survival Rate
timeFrame: 6 months after stereotactic radiosurgery (SRS)
Secondary outcomes:
measure: Central Nervous System (CNS) Progression-free Survival Rate
timeFrame: 12 months after stereotactic radiosurgery (SRS)
measure: Median Time to CNS Disease Progression
timeFrame: up to12 months from SRS
measure: Overall Survival
timeFrame: 12 months from SRS
measure: Time to Progression
timeFrame: at 3 yrs from SRS
measure: Rate of Local Failure at 12 Months
timeFrame: 12 months
measure: Neurocognitive Effects
timeFrame: at 2 months after treatment
measure: Safety and Tolerability
timeFrame: 3 years from study start
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: David M. Peereboom, MD
role: PRINCIPAL_INVESTIGATOR
References: