Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

Completed · Phase 1

Conditions studied: Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when given together with radiation therapy in treating patients with brain metastases caused by solid tumors.

Key facts

Study ID

NCT00837928

Run by

John Grecula

People needed

18

Starts

2009-02-19

Expected to finish

2015-01-08

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed cancer with 1 to 4 brain metastases imaged by MRI/CT scans not involving thalamus, basal ganglia or brain stem.
• No cancer originating in central nervous system
• Candidate for clinically indicated surgery to resect brain lesions.
• Karnofsky score of at least 60
• At least 18 years of age
• Life expectancy of more than two months

You may not qualify if…

• Evidence of leptomeningeal metastases.
• Need immediate treatment to prevent neurological deterioration.
• Prior brain radiotherapy or surgery for current brain metastases.
• Radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
• Absolute neutrophil count (ANC)<1500/mm3 or platelets <50,000/mms.
• Brain metastasis diameter greater than 5 cm.
• Not pregnant or nursing
• More than 3 weeks since prior chemotherapy.
• No evidence of ischemia on EKG and/or reduced cardiac ejection fraction (i.e., < 50%) on ECHO.
• No known sensitivity or allergy to bendamustine hydrochloride or mannitol
• No more than 3 prior cytotoxic chemotherapy regimens
• No unresolved persistent toxicities for 4 weeks from prior chemotherapy or 6 weeks for nitrosoureas.
• Calculated creatinine clearance <40 ml/min.

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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