Clinical Trial Details
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NCT00837928 : Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
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