Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies
- Determine the recommended phase II dose of bendamustine hydrochloride when administered
in combination with stereotactic radiotherapy for the treatment of patients with 1-3
brain metastases from solid malignancies.
- Determine bendamustine hydrochloride pharmacokinetics and correlate this to
bendamustine hydrochloride levels in brain metastases, brain margin, arachnoid,
cerebral spinal fluid, and plasma acquired at the time of surgery.
- Assessment of local control of brain metastases.
OUTLINE: This is a dose-escalation study of bendamustine hydrochloride.
Patients with no potentially resectable lesion(s) receive bendamustine hydrochloride IV over
30 minutes and stereotactic radiotherapy once daily for 5 days.
Patients with potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30
minutes on days 1-3 and undergo surgery on day 3. At least 4 weeks after surgery, these
patients receive adjuvant bendamustine hydrochloride and stereotactic fractionated
radiotherapy as above (in patients with no potentially resectable lesion[s])
Blood samples are collected periodically for pharmacokinetic studies. Cerebrospinal fluid,
arachnoid, tumor margin, and tumor samples are also collected during surgery for correlative
After completion of study treatment, patients are followed every 3 months for 21 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.
John C. Grecula, MD
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|