Status:
COMPLETED
Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors
Lead Sponsor:
John Grecula
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 radia...
Detailed Description
OBJECTIVES: Primary * Determine the recommended phase II dose of bendamustine hydrochloride when administered in combination with stereotactic radiotherapy for the treatment of patients with 1-4 bra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00837928
Start Date
February 19 2009
End Date
January 8 2015
Last Update
May 17 2018
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210