Brain Metastases Clinical Trial
Official title:
Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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