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

NCT00910039 | Terminated Phase 2 Results DMC

• 2 other identifiers: CASE1308P30CA043703
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Central Nervous System (CNS) Progression-free Survival Rate

  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.

  6 months after stereotactic radiosurgery (SRS)

Secondary Outcomes (7)

• Central Nervous System (CNS) Progression-free Survival Rate

  12 months after stereotactic radiosurgery (SRS)

• Median Time to CNS Disease Progression

  up to12 months from SRS

• Overall Survival

  12 months from SRS

• Time to Progression

  at 3 yrs from SRS

• Rate of Local Failure at 12 Months

  12 months

Study Arms (1)

Sunitinib malate

EXPERIMENTAL

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.

Drug: sunitinib malate; Other: cognitive assessment

Interventions

sunitinib malate DRUG

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.

Also known as: SUNITINIB L-Malate salt, SU010398; PHA-290940AD, Sutent, SUNITINIB

Sunitinib malate

cognitive assessment OTHER

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).

Also known as: Cognitive Function Tests:, Memory Hopkins Verbal Learning Test, Verbal fluency Controlled Oral Word Association, Visual-motor speed Trail Making Test Part A, Executive Function Trail Making Test Part B, Motor dexterity Grooved Pegboard 3, Function Test:, Quality of life (QOL) was evaluated with a self-report measure (FACT-BRREF).

Sunitinib malate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Sunitinib; Mental Status and Dementia Tests; Quality of Life

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: David Peereboom, MD
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

peerebd@ccf.org

216-445-6068

Study Officials

• David M. Peereboom, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2014
• Last Updated: September 29, 2014
• Results First Posted: October 1, 2013

Record last verified: 2014-09

Locations

US (3)