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Brief Title: Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors
Official Title: Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
Study ID: NCT00879073
Brief Summary: The purpose of this study is to: * Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy (WBRT) * To determine the plasma pharmacokinetics (a blood test to see how much of the drug is getting into the patient's system and how long it lasts in the system) of Bendamustine * To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the brain and spinal cord) of study patients Bendamustine is approved by the Food and Drug Administration (FDA) for chronic lymphocytic leukemia. However, Bendamustine will be used in this study as an investigational agent.
Detailed Description: Bendamustine will be started in the first group at a dose of 60 mg/m²; patients in group 2 will be given Bendamustine at a dose of 80 mg/m²; patients in Group 3 will be given Bendamustine at 100 mg/m². Each cohort will receive Bendamustine once weekly for a total of 4 weeks. Approximately 3-6 patients enrolled in this study will receive lumbar punctures. Patients will be told before study enrollment whether they will have a lumbar puncture to withdraw CSF.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Name: Edward Pan, M.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR