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Clinical Trial VICCRAD1060

Title

A Phase I Trial of Sorafenib and Stereotactic Radiosurgery for Patients with 1-4 Brain Metastases

Principal Investigator(s)

Bapsi Chak

Details

  • Protocol No. VICCRAD1060
  • Open Date: 02/15/2011
  • Staging: Phase I
  • Age Group: Adults
  • Scope: Local
  • Objective: To determine the safety, tolerability and maximum tolerated dose (MTD) of sorafenib, when administered in combination with SRS to patients with 1-4 metastatic brain tumors.
  • Disease Sites: Neuro-Oncology
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
  • Drugs: BAY 43-9006 (Sorafenib); Sorafenib (Nexavar)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01276210
  • Secondary Protocol No: Not Specified

Description

You are being asked to take part in this research study because you have cancer that has spread to the brain (brain metastases). This is a clinical trial (a type of research study). Clinical trials include only patients who choose to take part. Please take your time to make your decision and discuss it with your friends and family. The purpose of this study is to assess the safety, tolerability, and anti-tumor activity of sorafenib when given in combination with stereotactic radiosurgery (SRS) in the treatment of 1-3 brain metastases.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Histologically confirmed cancer with 1-4 brain metastases (except lymphoma or small cell histologies)
• ECOG PS 0 or 1
• Patients are candidates for stereotactic radiosurgery as determined by the treating radiation oncologist. Intra-cranial tumors must measure 4cm or less in greatest dimension. Patients may have received prior neurosurgical resection(s) of intra-cranial metastases if their operation(s) was (were) completed at least 6 months prior to study enrollment. Patients may have had prior whole brain radiation therapy (WBRT) if it was completed at least 6 months prior to study enrollment.
• Age ≥ 18 years and willing and able to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
• INR < 1.5 or a PT/PTT within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly (INR must be therapeutic in the range of 2-3)
Subjects must receive 1st dose of sorafenib 5-7 days prior to administration of Stereotactic Radiosurgery.
Exclusion Criteria:
• Congestive heart failure > class II NYHA; patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
• Unable to undergo brain MRI
• CNS metastases from lymphoma or small cell lung cancer
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Uncontrolled hypertension defined as systolic blood pressure > 140mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
• Active clinically serious infection > CTCAE v 4.0 Grade 2
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
• Pulmonary hemorrhage/bleeding event >= CTCAE v 3.0 Grade 2 within 4 weeks of first dose of study drug
• Any other hemorrhage/bleeding event >= CTCAE v 3.0 Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Any drug that results in hepatic enzyme induction such as anti-convulsants (dilantin, depakote, tegretol, phenobarbital); keppra is allowed
• Evidence or history of bleeding diathesis or coagulopathy
• Any pulmonary hemorrhage CTCAE v 4.0 Grade 2 or higher within 4 weeks of first study drug
• Any other bleeding or hemorrhage CTCAE v 4.0 Grade 3 or higher within 4 weeks of first drug
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
• Use of St. John's Wort or rifampin (rifampicin) within the last 8 weeks
• Known or suspected allergy to sorafenib
• Any condition that impairs patient's ability to swallow whole pills
• Concurrent investigational drugs
• Concurrent steroids are allowed if Dexamethasone dose is =< 16mg daily; if feasible, steroids should be weaned off once sorafenib has been initiated
• Prior therapy with sorafenib or other tyrosine kinase inhibitors within the last 12 months; patients are allowed to have been on prior bevacizumab therapy as long as it was stopped at least 6-8 weeks prior to enrolling on this trial
• Any malabsorption problem
• Hemoglobin =< 9.0 g/dl
• Absolute neutrophil count (ANC) =< 1,500/mm^3
• Platelet count =< 100,000/mm^3
• Total bilirubin >= 1.5 times upper limit of normal (ULN)
• ALT and AST >= 2.5 times the ULN ( =< 5 x ULN for patients with liver involvement)
• Creatinine >= 1.5 times ULN
• Women of childbearing potential with a positive serum pregnancy test performed within 7 days prior to the start of treatment; women and men of childbearing potential that do not agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men who do not agree to use adequate birth control for at least three months after the last administration of sorafenib
• All toxicities from prior therapies must have resolved to CTCAE v3.0 Grade I or better by the time of study enrollment