Carboplatin and Bevacizumab for Recurrent Ependymoma (NCT01295944) | Clinical Trial Compass
CompletedPhase 2
Carboplatin and Bevacizumab for Recurrent Ependymoma
United States35 participantsStarted 2011-04-27
Plain-language summary
The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent ependymoma. The safety of this drug combination will also be studied.
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 proven intra-cranial or spinal ependymoma or anaplastic ependymoma. There must be pathologic or imaging confirmation of tumor progression or regrowth.
* The patient must have at least 1 block of tissue or 15 unstained slides at a minimum available for central pathology review and molecular profiling of the tissue sample.
* All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
* Patients must be greater than or equal to 18 years old.
* Patients must have a Karnofsky performance status of \> 60.
* Patients must have adequate bone marrow function (white blood cell (WBC) greater than or equal to 3,000/microliter, absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3, platelet count of greater than to equal to 100,000/mm\^3, and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (Serum glutamic oxaloacetic transaminase (SGOT) \[aspartate aminotransferase (AST) \<92.5 Units/L\] and bilirubin less than or equal to 1.5 mg/dL), and adequate renal function (creatinine \< 1.5 mg/dL and calculated creatinine clearance greater than or equal to 60 cc/min) before starting therapy. Eligibility level for hemoglobin may be reached by transfusion.
* Patients must have shown unequivocal radiographic evidence for tumor progression by magnetic resonance imaging (MRI…
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.
1This trial used carboplatin and bevacizumab together for recurrent ependymoma — has the completed data been published, and what did the results show about how many patients were actually progression-free at one year?
2Since this is a Phase 2 trial that has already finished, what does that mean for how confident we can be about the safety and effectiveness of this carboplatin and bevacizumab combination before considering it as an option?
3For someone with recurrent ependymoma or anaplastic ependymoma like mine, would the standard of care treatment options be worth trying first, or does the evidence from this completed trial suggest this combination might be a stronger path to discuss?
4Bevacizumab can have significant side effects like bleeding or blood pressure issues — based on the results from this trial, how did patients generally tolerate combining it with carboplatin, and are those risks relevant to my specific situation?
5Are there any currently open or more recent trials building on what this study found, that might be worth looking into alongside or instead of this completed research?
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
Percentage of Participants That Have Progressive Free Survival (PFS) After 1 Year