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 range18 Years
SexALL
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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…
What they're measuring
1
Percentage of Participants That Have Progressive Free Survival (PFS) After 1 Year