Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases
This study is ongoing, but not recruiting participants.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00910039
First received: May 28, 2009
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cognitive/Functional Effects Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sunitinib malate Procedure: cognitive assessment Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases |
Resource links provided by NLM:
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine
Methamphetamine
Malic acid
Sunitinib malate
Sunitinib
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- CNS progression-free survival rate [ Time Frame: 6 months after radiosurgery ] [ Designated as safety issue: No ]defined as the time from stereotactic radiosurgery until disease progression or death due to any cause (all-cause mortality).
Secondary Outcome Measures:
- Rate of local failure at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Rate of local vs regional failure -rates of progression at site of stereotactic radiosurgery (local failure) vs progression anywhere else in CNS (regional failure).
- Median time to CNS disease progression [ Time Frame: day 28 of even numbered cycles ] [ Designated as safety issue: No ]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.
- Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]The percentage of subjects surviving at least six months from stereotactic radiosurgery.
- Time to progression [ Time Frame: day 28 of even numbered cycles ] [ Designated as safety issue: No ]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.
- Safety and tolerability [ Time Frame: Beginning and end of each cycle ] [ Designated as safety issue: Yes ]Patients will be monitored closely for toxicity, and the SUNITINIB dose may be adjusted according to individual patient tolerance.
- Neurocognitive effects [ Time Frame: Pre and post tx and even cycles during tx ] [ Designated as safety issue: No ]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 (7). This index is derived from the standard error of measurement (SEM) for each test in the battery.
| Enrollment: | 14 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sunitinib malate |
Drug: sunitinib malate
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.
Other Names:
Procedure: cognitive assessment
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 (7). This index is derived from the standard error of measurement (SEM) for each test in the battery.
Other Names:
Procedure: quality-of-life assessment
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 (7). This index is derived from the standard error of measurement (SEM) for each test in the battery.
Other Name: Quality of life Functional Assessment of Cancer Therapy with Brain Module (6)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910039
Locations
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | David M. Peereboom, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00910039 History of Changes |
| Other Study ID Numbers: | CASE1308, P30CA043703, CASE1308 |
| Study First Received: | May 28, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Case Comprehensive Cancer Center:
|
cognitive/functional effects tumors metastatic to brain unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013