COG-ACNS0821
| Clinical Trial Title | Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors |
| Trial Status | Closed to Enrollment |
| Start Date | 03/24/2011 |
| Location | randall-childrens-hospital-at-legacy-emanuel |
| Trial Type | Pediatric Cancer (Oncology) |
| Specific Condition | Medulloblastoma (Recurrent / Refractory) |
| Description | This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors. |
| Eligibility Criteria | Age: must be no greater than 21 years of age at the time of study enrollment Diagnosis: medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy Patients with pineoblastoma are eligible Must have had histologic verification of malignancy at original diagnosis or at the time of recurrence Must have measurable residual disease; diffuse leptomeningeal disease is not considered measurable Life expectancy: >8 weeks Patients must have experienced at least one and at most two relapses prior to study enrollment Patients with primary refractory disease are eligible Patients must have fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients must have recovered from any surgical procedure before enrolling on this study (lumbar punctures or placement of PICC lines are acceptable at any time prior or during therapy) Hypertension must be well controlled Adequate bone marrow, kidney, liver, and coagulation function Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants |
| IRB Number | |
| Notes | https://clinicaltrials.gov/ct2/show/NCT01217437 Study status is: Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled. |
| Principal Investigator | Janice Olson, MD |
| Contact Name | Children's Cancer and Blood Disorders Program |
| Contact Phone | (503) 276-9300 |
| Contact Fax | |
| Contact E-Mail |
