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SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cognitive/Functional Effects, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CNS progression-free survival rate

Outcome Description:

defined as the time from stereotactic radiosurgery until disease progression or death due to any cause (all-cause mortality).

Outcome Time Frame:

6 months after radiosurgery

Safety Issue:

No

Principal Investigator

David M. Peereboom, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE1308

NCT ID:

NCT00910039

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cognitive/functional effects
  • tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Henry Ford Health SystemDetroit, Michigan  48202
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195