| Inclusion Criteria: | 1) Histologically proven ependymoma or anaplastic ependymoma. There must be pathologic or imaging confirmation of tumor progression or regrowth. The patients histologic diagnosis must be confirmed on Central Pathology Review prior to registration Step 2.
2) History and physical examination, including neurologic examination, within 2 weeks prior to registration.
3) Patients must be able to undergo brain or spine MRI scans with intravenous gadolinium, based on tumor location(s) within 14 days prior to registration.
4) Patients must be on a steroid dose that has been stable or decreasing for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required.
5) Karnofsky performance status >/= 70
6) Age >/= 18
7) CBC/differential obtained within 14 days prior to registration, with adequate bone marrow function defined as follows: 1) Absolute neutrophil count (ANC) >/= 1,500/mm^3. 2) Platelets >/= 100,000 cells/mm^3. 3) Hemoglobin >/= 10.0 gm/dL (Note: The use of transfusion or other intervention to achieve Hgb >/= 10.0 is acceptable). 4) White blood cell count (WBC) >/= 3,000/mcL.
8) Adequate liver function within 14 days prior to registration, defined as follows: SGPT [ALT] < 2.5 times the upper limit of normal, Bilirubin </= 1.6 mg/dL
9) Adequate renal function within 14 days prior to registration, defined as follows: Creatinine < 1.7 mg/dL
10) Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of: 1) 28 days from the administration of any investigational agent. 2) 28 days from administration of prior cytotoxic therapy with the following exceptions: (a) 14 days from administration of vincristine. (b) 42 days from administration of nitrosoureas. (c) 21 days from administration of procarbazine.
11) ( 11. continued) 3) 7 days from administration of non-cytotoxic agents [e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)]. 4) 28 days from prior radiation therapy.
12) Patients must have recovered from the effects of surgery and a minimum of 14 days must have elapsed from the day of surgery to the day of registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
13) Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, an MRI should be done no later than 96 hours in the immediate postoperative period or at least 4 weeks postoperatively, within 14 days prior to registration. If the " within 96-hour of surgery " scan is more than 14 days before registration, the scan needs to be repeated.
14) Patients must sign study-specific informed consent and authorization for the release of their protected health information prior to registration. Patients must be registered in the MDACC OMCR database prior to treatment with study drug.
15) Women of childbearing potential must have a negative beta-HCG pregnancy test documented within 14 days prior to registration.
16) Women of childbearing potential and male participants must practice adequate contraception
17) All patients must have an LVEF measurement of at least 50% by Echo or MUGA (if clinically indicated) within 14 days prior to registration. The method used for LVEF assessment in an individual subject must be the same throughout the trial. |