Clinical trial · Interventional
Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases
SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases
NCT00910039CI-TRIAL-00015720terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Other | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib malate
- description
- 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.
- interventionNames
- Drug: sunitinib malate
- Other: cognitive assessment
Primary outcomes (1)
- measure
- Central Nervous System (CNS) Progression-free Survival Rate
- timeFrame
- 6 months after stereotactic radiosurgery (SRS)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.