Kidney Cancer Clinical Trial

Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain

Summary

This phase II trial is studying how well sorafenib works in treating patients with kidney cancer that has spread to the brain. Sorafenib 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.

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Full Description

PRIMARY OBJECTIVES:

I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC) metastatic to the brain treated with sorafenib.

SECONDARY OBJECTIVES:

I. Determine the toxicity of sorafenib in patients with RCC metastatic to the brain.

II. Determine whether the effect of sorafenib on RCC metastatic to the brain is similar to its effect on non-brain metastatic sites.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed renal cell carcinoma metastatic to the brain
Measurable disease in the brain

Meets 1 of the following criteria:

No prior brain-specific therapy AND no CNS symptoms referable to the brain lesion(s) (with or without concurrent steroid therapy)
CNS symptoms referable to the brain lesion(s) AND received primary therapy for the brain lesion(s)

PATIENT CHARACTERISTICS:

Blood pressure < 140/90 mm Hg on 2 separate occasions, taken at least 24 hours apart, within the past 6 weeks (patients on stable anti-hypertensive regimens allowed)
ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
Bilirubin < 1.5 times upper limit of normal (ULN)
ALT/AST < 2.5 times ULN
Estimated glomerular filtration rate > 30 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to swallow pills or comply with an oral treatment regimen
No history of a bleeding diathesis or requirement for full-dose anticoagulation
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
No clinical or radiologic evidence of bowel obstruction or perforation

No other uncontrolled intercurrent illness including, but not limited to, any of the following:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
More than 4 weeks since prior radiotherapy to sites outside of the brain and recovered
More than 8 weeks since prior standard external-beam radiotherapy to the brain unless there is evidence of in-brain progression
No prior complete surgical resection or radiosurgery of all known brain metastases unless there is evidence of in-brain progression
No prior sorafenib, sunitinib malate, bevacizumab, or any other agent targeting the platelet-derived growth factor receptor (PDGFR) or vascular endothelial growth factor receptor (VEGFR) kinase cascade
No other concurrent investigational agents

No concurrent enzyme-inducing anti-seizure medications, including phenytoin, phenobarbital, carbamazepine, or primidone

Concurrent non-enzyme-inducing anti-seizure medications allowed
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent hematopoietic growth factors except erythropoietin
No concurrent ketoconazole, itraconazole, or ritonavir
No concurrent grapefruit juice
No concurrent Hypericum perforatum (St. John's wort)
No concurrent chemotherapy
No concurrent hormonal therapy except steroids for adrenal failure and/or control of CNS edema or hormones for non-disease related conditions (e.g., insulin for diabetes)
No concurrent palliative radiotherapy
No other concurrent anticancer therapy
Concurrent bisphosphonates allowed

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT00301847

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 12 Locations for this study

See Locations Near You

University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston Illinois, 60201, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield Illinois, 62701, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46885, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Oncology Care Associates, PLLC
Saint Joseph Michigan, 49085, United States
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis Missouri, 63141, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT00301847

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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