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Cognitive/Functional EffectsPhase 2NCT00910039

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

A Phase 2 study testing sunitinib malate and cognitive assessment in people with Cognitive/Functional Effects and Metastatic Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sunitinib malate and cognitive assessment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
Apr 2009to Apr 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

  • Henry Ford Health System

    Detroit, Michigan, 48202

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
sunitinib malate, cognitive assessment
Keywords
cognitive/functional effects, tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Medical subject headings
Neoplasm Metastasis, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib malateDrug

    Also called SUNITINIB L-Malate salt, SU010398; PHA-290940AD, Sutent, SUNITINIB

    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.

  • cognitive assessmentOther

    Also called Cognitive Function Tests:, Memory Hopkins Verbal Learning Test, Verbal fluency Controlled Oral Word Association, Visual-motor speed Trail Making Test Part A

    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).

Study groups in NCT00910039
Study groupRoleWhat they receive
Sunitinib malateExperimentalOral 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.
Receives: Drug: sunitinib malate; Other: cognitive assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after stereotactic radiosurgery (SRS)

Secondary outcomes (7)

  1. Central Nervous System (CNS) Progression-free Survival Rate

    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.

    Measured: 12 months after stereotactic radiosurgery (SRS)

  2. Median Time to CNS Disease Progression

    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.

    Measured: up to12 months from SRS

  3. Overall Survival

    The number of subjects surviving at least 12 months from stereotactic radiosurgery.

    Measured: 12 months from SRS

  4. Time to Progression

    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.

    Measured: at 3 yrs from SRS

  5. Rate of Local Failure at 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).

    Measured: 12 months

  6. Neurocognitive Effects

    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

    Measured: at 2 months after treatment

  7. Safety and Tolerability

    Number of patients that experienced treatment-related G 3-4 adverse events.

    Measured: 3 years from study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJan 2012
  4. Study completionApr 2014

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910039
Sponsor's protocol ID
CASE1308
Other IDs
P30CA043703, CASE1308
Status last verified
Sep 2014
First submitted
28 May 2009
Last updated
29 Sep 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate and cognitive assessment in people with Cognitive/Functional Effects and Metastatic Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Nervous System (CNS) Progression-free Survival Rate (time frame: 6 months after stereotactic radiosurgery (SRS)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910039.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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