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

Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cognitive/Functional Effects; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: sunitinib malate (Drug); cognitive assessment (Other)

Phase: Phase 2

Status: Terminated

Sponsored by: Case Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
David M. Peereboom, MD, Principal Investigator, Affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Central Nervous System (CNS) Progression-free Survival Rate

Secondary outcome:

Central Nervous System (CNS) Progression-free Survival Rate

Median Time to CNS Disease Progression

Overall Survival

Time to Progression

Rate of Local Failure at 12 Months

Neurocognitive Effects

Safety and Tolerability

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Henry Ford Health System, Detroit, Michigan 48202, United States

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio 44106, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio 44195, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2009
Last updated: September 25, 2014

Page last updated: August 23, 2015

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