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Spots Global Cancer Trial Database for Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

Bendamustine

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Contact Details

Name: Edward Pan, M.D.

Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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