Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors
Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies
2 other identifiers
interventional
18
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedStudy Start
First participant enrolled
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2015
CompletedMay 17, 2018
May 1, 2018
5.9 years
February 5, 2009
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.
up to 4 years
Secondary Outcomes (3)
Pharmacokinetics of bendamustine
up to 4 years
Levels of bendamustine hydrochloride in the brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma
up to 4 years
Local control of brain metastases
up to 4 years
Study Arms (1)
Bendamustine and Fractionated stereotactic radiotherapy
EXPERIMENTALBendamustine 40 mg/m2 and will be administered IV on days 1,2,and 3 prior to surgery on each day of SRT (Sterotactic radiation therapy). Laboratory biomarker analysis will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. Pharmacokinetic samples will not be collected from patients who begin SRT on day 1). Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine) Stereotactic fractionated radiation therapy starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri). Concurrent Bendamustine is administered on Days of Stereotactic Radiotherapy (Arm 1: 40 mg/m2/ Day; Arm 2: 50 mg/m2/day).
Interventions
40 mg/m2 will be administered IV on days 1,2,and 3 prior to surgery.on each day of SRT.
samples will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. PK samples will not be collected from patients who begin SRT on day 1).
Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine)
Starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri)
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- John Greculalead
- National Comprehensive Cancer Networkcollaborator
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John C. Grecula, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
February 19, 2009
Primary Completion
January 8, 2015
Study Completion
January 8, 2015
Last Updated
May 17, 2018
Record last verified: 2018-05