Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

25 september 2014 uppdaterad av: Case Comprehensive Cancer Center

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

14

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Henry Ford Health System
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
      • Cleveland, Ohio, Förenta staterna, 44106
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

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.
Andra namn:
  • Sutent
  • SUNITINIB L-malatsalt
  • SU010398; PHA-290940AD
  • SUNITINIB
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).
Andra namn:
  • 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Central Nervous System (CNS) Progression-free Survival Rate
Tidsram: 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.
6 months after stereotactic radiosurgery (SRS)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Central Nervous System (CNS) Progression-free Survival Rate
Tidsram: 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.
12 months after stereotactic radiosurgery (SRS)
Median Time to CNS Disease Progression
Tidsram: 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.
up to12 months from SRS
Overall Survival
Tidsram: 12 months from SRS
The number of subjects surviving at least 12 months from stereotactic radiosurgery.
12 months from SRS
Time to Progression
Tidsram: 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.
at 3 yrs from SRS
Rate of Local Failure at 12 Months
Tidsram: 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).
12 months
Neurocognitive Effects
Tidsram: 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
at 2 months after treatment
Safety and Tolerability
Tidsram: 3 years from study start
Number of patients that experienced treatment-related G 3-4 adverse events.
3 years from study start

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: David M. Peereboom, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2009

Primärt slutförande (Faktisk)

1 januari 2012

Avslutad studie (Faktisk)

1 april 2014

Studieregistreringsdatum

Först inskickad

28 maj 2009

Först inskickad som uppfyllde QC-kriterierna

28 maj 2009

Första postat (Uppskatta)

29 maj 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 september 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2014

Senast verifierad

1 september 2014

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera