drugset / Trial / NCT00879073
Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors
Phase 1
Terminated
12 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Cephalon · collabNational Comprehensive Cancer Network · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-04
- Primary completion
- 2012-11
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 100 mg/m2 | Intravenous |