Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors (NCT00837928) | Clinical Trial Compass
CompletedPhase 1
Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors
United States18 participantsStarted 2009-02-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.